SNPMiner Trials by Shray Alag

NCT00511368 (37) NCT00460382 (36) NCT04504071 (35) NCT03783286 (33) NCT04172597 (32) NCT02404233 (29) NCT00959894 (28) NCT00706147 (28) NCT00121017 (28) NCT01685801 (27) NCT04513626 (26) NCT01736761 (26) NCT04495348 (24) NCT02673398 (23) NCT02499978 (22) NCT01605084 (21) NCT04254705 (21) NCT02069834 (21) NCT00939770 (18) NCT01792570 (18) NCT01199939 (18) NCT00356616 (18) NCT02728258 (17) NCT02707601 (17) NCT02770508 (16) NCT00711009 (16) NCT00630864 (16) NCT00491556 (15) NCT04085315 (15) NCT02616029 (15) NCT00830804 (15) NCT04681820 (15) NCT01170962 (14) NCT00984152 (14) NCT03953898 (14) NCT00727597 (14) NCT03212274 (14) NCT01369199 (13) NCT00337467 (13) NCT00098293 (13) NCT01368497 (13) NCT02159599 (13) NCT00424814 (12) NCT04432454 (12) NCT02527096 (12) NCT01849003 (12) NCT03781063 (12) NCT03683524 (11) NCT01614457 (11) NCT00460746 (11) NCT00993148 (11) NCT03061331 (11) NCT02494882 (11) NCT03068312 (11) NCT04453436 (11) NCT01521338 (10) NCT02725567 (10) NCT01614470 (10) NCT01423812 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NCT02554591 (5) NCT01501604 (5) NCT02716116 (5) NCT01136460 (5) NCT00187655 (5) NCT00350272 (5) NCT00837135 (5) NCT03202862 (5) NCT01707199 (5) NCT03839342 (5) NCT01323010 (4) NCT02248324 (4) NCT01698905 (4) NCT01737359 (4) NCT01306045 (4) NCT02804100 (4) NCT01456676 (4) NCT00588172 (4) NCT03434418 (4) NCT03593993 (4) NCT01804140 (4) NCT02882308 (4) NCT03497767 (4) NCT04106024 (4) NCT02716311 (4) NCT04405674 (4) NCT03599518 (4) NCT01675778 (4) NCT01604122 (4) NCT01297777 (4) NCT04519970 (4) NCT00705679 (4) NCT04147351 (4) NCT04129502 (4) NCT03976856 (4) NCT02335944 (4) NCT04625647 (4) NCT03948763 (4) NCT03255083 (4) NCT04002830 (4) NCT02635815 (4) NCT03066206 (4) NCT01331642 (4) NCT00557245 (4) NCT01922583 (4) NCT02893332 (4) NCT03592888 (4) NCT02257424 (4) NCT03874858 (4) NCT00017732 (4) NCT00187720 (4) NCT02593539 (4) NCT01185587 (4) NCT04439292 (4) NCT03884348 (4) NCT01309243 (4) NCT03209063 (4) NCT04160546 (4) NCT03292302 (4) NCT02418234 (4) NCT02535338 (3) NCT02192697 (3) NCT03410043 (3) NCT03845296 (3) NCT02914990 (3) NCT02113813 (3) NCT01532011 (3) NCT04340388 (3) NCT00962533 (3) NCT03856411 (3) NCT04049266 (3) NCT02973763 (3) NCT02926092 (3) NCT00271973 (3) NCT04256941 (3) NCT03812809 (3) NCT02954523 (3) NCT01784068 (3) NCT03446417 (3) NCT02841579 (3) NCT02025114 (3) NCT01288521 (3) NCT01385683 (3) NCT02279004 (3) NCT00998582 (3) NCT03111901 (3) NCT01352715 (3) NCT01619774 (3) NCT01045369 (3) NCT02246998 (3) NCT03969823 (3) NCT00895596 (3) NCT02398929 (3) NCT00724711 (3) NCT04029350 (3) NCT03737994 (3) NCT01443806 (3) NCT02629822 (3) NCT03463525 (3) NCT00710112 (3) NCT03623750 (3) NCT04283955 (3) NCT02743923 (3) NCT01016106 (3) NCT01259089 (3) NCT03971474 (3) NCT02917993 (3) NCT02368990 (3) NCT00279110 (3) NCT02485652 (3) NCT00312169 (3) NCT04541407 (3) NCT02769286 (3) NCT00747487 (3) NCT04267913 (3) NCT01429597 (3) NCT04023617 (3) NCT03790228 (3) NCT01759888 (3) NCT04429152 (3) NCT01810718 (3) NCT02725632 (3) NCT01090011 (3) NCT04544111 (3) NCT02926768 (3) NCT02981108 (3) NCT02459743 (3) NCT00654823 (3) NCT01037127 (3) NCT04439305 (3) NCT01028222 (3) NCT01542411 (3) NCT01031446 (3) NCT02726269 (3) NCT01892644 (3) NCT03260491 (3) NCT01802632 (3) NCT02720094 (3) NCT02630186 (3) NCT01627132 (3) NCT02690675 (3) NCT01013506 (3) NCT04252339 (3) NCT02496663 (3) NCT03386955 (3) NCT03394118 (3) NCT04212702 (3) NCT01754025 (3) NCT01160276 (3) NCT00121979 (3) NCT03228277 (3) NCT04351555 (3) NCT01243346 (3) NCT04510415 (3) NCT02796274 (3) NCT02774005 (3) NCT02064491 (3) NCT04233021 (3) NCT03799601 (3) NCT00260260 (3) NCT02094261 (3) NCT04245085 (3) NCT03058094 (3) NCT01282151 (3) NCT02520778 (3) NCT03161808 (3) NCT04181060 (3) NCT01342679 (3) NCT01443273 (3) NCT01593254 (3) NCT04433481 (3) NCT02529995 (3) NCT03502850 (3) NCT02771314 (3) NCT03823807 (3) NCT03270527 (3) NCT02688881 (3) NCT01005602 (3) NCT02442349 (3) NCT02684591 (2) NCT02282267 (2) NCT03381430 (2) NCT02178397 (2) NCT03608215 (2) NCT02603107 (2) NCT03370770 (2) NCT03322696 (2) NCT03333343 (2) NCT00525473 (2) NCT03127449 (2) NCT01781026 (2) NCT02503722 (2) NCT00975871 (2) NCT03964233 (2) NCT03388099 (2) NCT02317016 (2) NCT03845270 (2) NCT03519958 (2) NCT03918304 (2) NCT02151721 (2) NCT02777658 (2) NCT01016444 (2) NCT02971501 (2) NCT03101254 (2) NCT03178617 (2) NCT01774721 (2) NCT03574753 (2) NCT01357655 (2) NCT01766713 (2) NCT02097225 (2) NCT00658164 (2) NCT03622593 (2) NCT02571036 (2) NCT00969137 (2) NCT00834665 (2) NCT02026011 (2) NCT03622580 (2) NCT03543683 (2) NCT01143493 (2) NCT03671538 (2) NCT04028778 (2) NCT00324961 (2) NCT01915576 (2) NCT02157883 (2) NCT01387022 (2) NCT03864042 (2) NCT03235245 (2) NCT03469960 (2) NCT02795884 (2) NCT04687241 (2) NCT00005541 (2) NCT01242813 (2) NCT03960645 (2) NCT00643058 (2) NCT03443336 (2) NCT02992860 (2) NCT02281760 (2) NCT02201602 (2) NCT04310007 (2) NCT04309019 (2) NCT03720665 (2) NCT00909532 (2) NCT00411944 (2) NCT01604681 (2) NCT01245062 (2) NCT00270231 (2) NCT03256136 (2) NCT03973918 (2) NCT00302692 (2) NCT00125281 (2) NCT02163733 (2) NCT02110407 (2) NCT00475176 (2) NCT03196882 (2) NCT01572818 (2) NCT02556333 (2) NCT04268550 (2) NCT02433717 (2) NCT03428126 (2) NCT01153763 (2) NCT02609776 (2) NCT01420211 (2) NCT03556176 (2) NCT03872440 (2) NCT01405079 (2) NCT03382795 (2) NCT02991950 (2) NCT00013598 (2) NCT03455764 (2) NCT02422628 (2) NCT03831932 (2) NCT03766490 (2) NCT02580474 (2) NCT00499577 (2) NCT02444884 (2) NCT01775943 (2) NCT03544814 (2) NCT01310036 (2) NCT01027663 (2) NCT01928160 (2) NCT01244438 (2) NCT00007150 (2) NCT04462081 (2) NCT02297425 (2) NCT02086071 (2) NCT01050400 (2) NCT03060590 (2) NCT01819428 (2) NCT02709668 (2) NCT02411448 (2) NCT03878719 (2) NCT04622072 (2) NCT04479306 (2) NCT03377023 (2) NCT01378026 (2) NCT03239145 (2) NCT04511533 (2) NCT00226551 (2) NCT02191891 (2) NCT04586270 (2) NCT04669535 (2) NCT04545710 (2) NCT02120222 (2) NCT02738593 (2) NCT00831272 (2) NCT04469543 (2) NCT00573495 (2) NCT04158544 (2) NCT00904150 (2) NCT02110056 (2) NCT02856893 (2) NCT02110043 (2) NCT02182986 (2) NCT04179890 (2) NCT00063232 (2) NCT02197234 (2) NCT03121235 (2) NCT01532089 (2) NCT03887169 (2) NCT02268864 (2) NCT01963845 (2) NCT00866736 (2) NCT03991013 (2) NCT02500927 (2) NCT04657991 (2) NCT02228382 (2) NCT02689570 (2) NCT01513785 (2) NCT02463435 (2) NCT03351361 (2) NCT04527549 (2) NCT03424759 (2) NCT02197247 (2) NCT02321046 (2) NCT04272034 (2) NCT04646824 (2) NCT04027647 (2) NCT02364609 (2) NCT02759835 (2) NCT04349865 (2) NCT00068159 (2) NCT00418015 (2) NCT04310397 (2) NCT03088176 (2) NCT03867175 (2) NCT00339209 (2) NCT00011258 (2) NCT01288430 (2) NCT01616199 (2) NCT03603262 (2) NCT03071705 (2) NCT00969930 (2) NCT00772408 (2) NCT02743468 (2) NCT00277342 (2) NCT04248829 (2) NCT01767454 (2) NCT00933127 (2) NCT03317873 (2) NCT03392246 (2) NCT01909453 (2) NCT03523104 (2) NCT00085917 (2) NCT02507921 (2) NCT03781752 (2) NCT03828422 (2) NCT02193282 (2) NCT03195452 (2) NCT04657289 (2) NCT02294487 (2) NCT01325441 (2) NCT02511106 (2) NCT02997501 (2) NCT04184921 (2) NCT00625092 (2) NCT01657786 (2) NCT01415011 (2) NCT02629523 (2) NCT01718847 (2) NCT02818023 (2) NCT00577707 (2) NCT01943422 (2) NCT00116636 (2) NCT04429542 (2) NCT01841463 (2) NCT03865511 (2) NCT03205267 (2) NCT01218477 (2) NCT02881320 (2) NCT01897480 (2) NCT02810990 (2) NCT04189757 (2) NCT01951001 (2) NCT04254939 (2) NCT03207867 (2) NCT00780949 (2) NCT03355768 (2) NCT00817089 (2) NCT02143466 (2) NCT04499053 (2) NCT01907776 (2) NCT00909727 (2) NCT01562028 (2) NCT03737253 (2) NCT00441974 (2) NCT02155465 (2) NCT04586335 (2) NCT00661999 (2) NCT02705339 (2) NCT04006340 (2) NCT04553887 (2) NCT04645225 (2) NCT03852290 (2) NCT02183922 (2) NCT03970239 (2) NCT00294372 (2) NCT03250676 (2) NCT03792074 (2) NCT00671892 (2) NCT00689182 (2) NCT00106379 (2) NCT01947023 (2) NCT00509652 (2) NCT03683251 (2) NCT02039986 (2) NCT03515837 (2) NCT04081688 (2) NCT03190005 (2) NCT01584648 (2) NCT02292654 (2) NCT03992456 (2) NCT03133546 (2) NCT01485809 (2) NCT01266967 (2) NCT04644315 (2) NCT02909712 (2) NCT00062764 (2) NCT01776684 (2) NCT03042221 (2) NCT01940809 (2) NCT04675008 (2) NCT01161537 (2) NCT01154816 (2) NCT01175759 (2) NCT01199731 (2) NCT02788058 (2) NCT03130452 (2) NCT04687423 (2) NCT01772732 (2) NCT02631447 (2) NCT02525692 (2) NCT02526537 (2) NCT03513666 (2) NCT02027961 (2) NCT03106779 (2) NCT04106544 (2) NCT04258943 (2) NCT00165984 (2) NCT00977470 (2) NCT02092974 (2) NCT03975231 (2) NCT03586453 (2) NCT01998295 (2) NCT02021305 (2) NCT03135197 (2) NCT00432016 (2) NCT04636437 (2) NCT03004625 (2) NCT03851445 (2) NCT04031898 (2) NCT04201418 (2) NCT01911507 (2) NCT03539224 (2) NCT01978236 (2) NCT00866177 (2) NCT00320879 (2) NCT00044304 (2) NCT01999179 (2) NCT00977730 (2) NCT02491775 (2) NCT00212147 (2) NCT02040064 (2) NCT00489385 (2) NCT01713023 (2) NCT04122729 (2) NCT03994393 (2) NCT02438722 (2) NCT02762448 (2) NCT00071903 (2) NCT00626223 (2) NCT01193829 (2) NCT03239340 (2) NCT02991274 (2) NCT02811354 (2) NCT03416530 (2) NCT02522988 (2) 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NCT03678506 (1) NCT02146365 (1) NCT04310943 (1) NCT02619955 (1) NCT02934139 (1) NCT00400387 (1) NCT00375219 (1) NCT00149305 (1) NCT03520946 (1) NCT02787447 (1) NCT04501614 (1) NCT03166631 (1) NCT04213313 (1) NCT02078531 (1) NCT02349048 (1) NCT02981784 (1) NCT04636593 (1) NCT01647711 (1) NCT03231722 (1) NCT03576937 (1) NCT04412070 (1) NCT00554866 (1) NCT03151161 (1) NCT01817166 (1) NCT02220855 (1) NCT02512627 (1) NCT04591197 (1) NCT03402048 (1) NCT04500704 (1) NCT02323724 (1) NCT01166126 (1) NCT03029858 (1) NCT04317599 (1) NCT00300573 (1) NCT00809211 (1) NCT01393730 (1) NCT02318368 (1) NCT02228369 (1) NCT04500717 (1) NCT01074398 (1) NCT03134131 (1) NCT02455167 (1) NCT01004497 (1) NCT02073279 (1) NCT02117817 (1) NCT00323687 (1) NCT01605981 (1) NCT01371955 (1) NCT04147767 (1) NCT04144257 (1) NCT03490123 (1) NCT04423185 (1) NCT02625337 (1) NCT03567629 (1) NCT03360929 (1) NCT00109278 (1) NCT04108156 (1) NCT02132598 (1) NCT00542451 (1) NCT01587573 (1) NCT00868465 (1) NCT01494402 (1) 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SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT04483947

Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene

A Phase 1, Double Blind, Randomised, Placebo-Controlled, Multi-centre, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD2693 in Patients With Non-alcoholic Steatohepatitis (NASH) With Fibrosis Stage 0-3 and Homozygous for the PNPLA3 148M Risk Allele

This study is intended to investigate the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD2693, following subcutaneous (SC) administration of multiple ascending doses in patients with Non-alcoholic Steatohepatitis (NASH) with fibrosis Stage 0 to 3 and homozygous for the patatin-like phospholipase domain-containing 3 (PNPLA3) 148M risk allele.

NCT04483947 Non-alcoholic Steatohepatitis (NASH)
MeSH:Fatty Liver Non-alcoholic Fatty Liver Disease
HPO:Hepatic steatosis

2 Interventions

Name: AZD2693

Description: Subcutaneous administration of AZD2693 multiple ascending doses in participants with NASH who are homozygous for the PNPLA3 148M risk allele
Type: Drug
Group Labels: 3

Cohort 1 Cohort 2 Cohort 3

Name: Placebo

Description: Participants randomised to placebo will receive the corresponding dose volume of solution as participants receiving AZD2693 within the same cohort
Type: Other
Group Labels: 3

Cohort 1 Cohort 2 Cohort 3


Primary Outcomes

Description: Safety and tolerability will be evaluated in terms of number of participants with adverse events and/or abnormal values of vital signs and/or clinical laboratory and/or electrocardiogram and/or renal assessments and/or blood assessments.

Measure: Number of participants with adverse events

Time: Up to 36 weeks (From Screening to Final Visit)

Secondary Outcomes

Description: The effect of AZD2693 on changes in LFC using magnetic resonance imaging-based proton density fat fraction (MRI-PDFF) compared to placebo will be assessed.

Measure: Absolute change from baseline to Week 8 and Week 12 in liver fat content (LFC)

Time: Baseline (Day 1), Week 8, Week 12

Description: The effect of AZD2693 on changes in LFC using magnetic resonance imaging-based proton density fat fraction (MRI-PDFF) compared to placebo will be assessed.

Measure: Percent change from baseline to Week 8 and Week 12 in liver fat content (LFC)

Time: Baseline (Day 1), Week 8, Week 12

Description: The effect of AZD2693 on circulating markers of hepatic health compared to placebo will be assessed.

Measure: Absolute change from baseline in Alanine Aminotransferase

Time: Up to 36 weeks (From Screening to Final Visit)

Description: The effect of AZD2693 on circulating markers of hepatic health compared to placebo will be assessed.

Measure: Percent change from baseline in Alanine Aminotransferase

Time: Up to 36 weeks (From Screening to Final Visit)

Description: The effect of AZD2693 on circulating markers of hepatic health compared to placebo will be assessed.

Measure: Absolute change from baseline in Aspartate Aminotransferase

Time: Up to 36 weeks (From Screening to Final Visit)

Description: The effect of AZD2693 on circulating markers of hepatic health compared to placebo will be assessed.

Measure: Percent change from baseline in Aspartate Aminotransferase

Time: Up to 36 weeks (From Screening to Final Visit)

Description: The effect of AZD2693 on circulating markers of hepatic health compared to placebo will be assessed.

Measure: Absolute change from baseline in Gamma Glutamyl Transferase

Time: Up to 36 weeks (From Screening to Final Visit)

Description: The effect of AZD2693 on circulating markers of hepatic health compared to placebo will be assessed.

Measure: Percent change from baseline in Gamma Glutamyl Transferase

Time: Up to 36 weeks (From Screening to Final Visit)

Description: The effect of AZD2693 on ELF score will be assessed.

Measure: Absolute change from baseline in Enhanced Liver Fibrosis (ELF) score

Time: Up to 36 weeks (From Screening to Final Visit)

Description: The effect of AZD2693 on ELF score will be assessed.

Measure: Percent change from baseline in ELF score

Time: Up to 36 weeks (From Screening to Final Visit)

Description: The effect of AZD2693 on cholesteryl ester 16:1/16:0 compared to placebo will be assessed.

Measure: Absolute change from baseline in plasma cholesteryl ester 16:1/16:0 ratio.

Time: Days 1, 8, 29, 36, 50, 64, and 78

Description: The effect of AZD2693 on cholesteryl ester 16:1/16:0 compared to placebo will be assessed.

Measure: Percent change from baseline in plasma cholesteryl ester 16:1/16:0 ratio.

Time: Days 1, 8, 29, 36, 50, 64, and 78

Description: The effect of AZD2693 on disease-specific biomarkers compared to placebo will be assessed.

Measure: Absolute change from baseline in disease-specific biomarkers

Time: Days 1, 8, 29, 36, 50, 64, and 78

Description: The effect of AZD2693 on disease-specific biomarkers compared to placebo will be assessed.

Measure: Percentage change from baseline in disease-specific biomarkers

Time: Days 1, 8, 29, 36, 50, 64, and 78

Description: To characterise effects of AZD2693 on lipid handling compared to placebo.

Measure: Absolute change from baseline β-Hydroxybutyrate and lipid profile

Time: Days 1, 8, 29, 36, 50, 64, and 78

Description: To characterise effects of AZD2693 on lipid handling compared to placebo

Measure: Percent change from baseline β-Hydroxybutyrate and lipid profile

Time: Days 1, 8, 29, 36, 50, 64, and 78

Description: Single dose PK parameters for AZD2693 and AZD2693 full-length antisense oligonucleotides (ASOs) will be derived from plasma concentrations

Measure: Maximum observed plasma drug concentration (Cmax)

Time: Day 1 to Day 162

Description: Single dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Time to reach maximum observed plasma concentration (tmax)

Time: Day 1 to Day 162

Description: Single and multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Terminal elimination rate constant, estimated by log-linear least-squares regression of the terminal part of the concentration-time curve (λz)

Time: Day 1 to Day 162

Description: Single and multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Apparent terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic concentration-time curve, estimated as (ln2)/λz (t½λz)

Time: Day 1 to Day 162

Description: Single and multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Area under the plasma concentration-time curve from time zero to 48 hours after dosing (AUC(0-48h))

Time: Day 1 to Day 162

Description: Single and multiple dose PK parameters for AZD2693 and AZD2693 full-length antisense oligonucleotides (ASOs) will be derived from plasma concentrations

Measure: Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUClast)

Time: Day 1 to Day 162

Description: Single dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Area under the concentration-time curve from time zero extrapolated to infinity. AUC is estimated by AUClast + Clast/λz where Clast is the last observed quantifiable concentration (AUC)

Time: Day 1 to Day 162

Description: Single dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Apparent total body clearance of drug from plasma after extravascular administration calculated as Dose/AUC (CL/F)

Time: Day 1 to Day 162

Description: Single and multiple dose PK parameters for AZD2693 and AZD2693 full-length antisense oligonucleotides (ASOs) will be derived from plasma concentrations

Measure: Mean residence time (MRT)

Time: Day 1 to Day 162

Description: Single and multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Time delay between drug administration and the first observed concentration in plasma (tlag)

Time: Day 1 to Day 162

Description: Single dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Apparent volume of distribution for parent drug at terminal phase (extravascular administration), estimated by dividing the apparent clearance (CL/F) by λz (Vz/F)

Time: Day 1 to Day 162

Description: Single and multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D)

Time: Day 1 to Day 162

Description: Single dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUC/D)

Time: Day 1 to Day 162

Description: Single dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Observed maximum plasma concentration divided by the dose administered (Cmax/D)

Time: Day 1 to Day 162

Description: Single and multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Time of the last quantifiable concentration (tlast)

Time: Day 1 to Day 162

Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Maximum observed plasma drug concentration at steady state (Cssmax)

Time: Day 1 to Day 162

Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Minimum observed drug concentration at steady state (Cssmin)

Time: Day 1 to Day 162

Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Time to reach maximum observed plasma concentration at steady state (tssmax)

Time: Day 1 to Day 162

Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Area under the concentration-time curve in the dose interval (AUCss)

Time: Day 1 to Day 162

Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Apparent total body clearance of drug from plasma after extravascular administration calculated as Dose/AUCss (CLss/F)

Time: Day 1 to Day 162

Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUCss/D)

Time: Day 1 to Day 162

Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Observed maximum plasma concentration divided by the dose administered (Cssmax/D)

Time: Day 1 to Day 162

Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Accumulation ratio based on Cmax (RacCmax)

Time: Day 1 to Day 162

Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Accumulation ratio based on AUC (RacAUC)

Time: Day 1 to Day 162

Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations

Measure: Temporal change parameter in systemic exposure (TCP)

Time: Day 1 to Day 162

Description: Urine PK parameters for AZD2693 full-length ASOs will be derived from the urine data

Measure: Amount of analyte excreted into the urine from time t1 to t2 (Ae(t1-t2))

Time: Day 1 and Day 57: Pre-dose and between 0-6 hours, 6-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-dose

Description: Urine PK parameters for AZD2693 full-length ASOs will be derived from the urine data

Measure: Cumulative amount of analyte excreted from time zero through the last sampling interval (Ae(0-last))

Time: Day 1 and Day 57: Pre-dose and between 0-6 hours, 6-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-dose

Description: Urine PK parameters for AZD2693 full-length ASOs will be derived from the urine data

Measure: Fraction of dose excreted unchanged into the urine from time t1 to t2 (fe(t1-t2))

Time: Day 1 and Day 57: Pre-dose and between 0-6 hours, 6-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-dose

Description: Urine PK parameters for AZD2693 full-length ASOs will be derived from the urine data

Measure: Cumulative fraction (%) of dose excreted unchanged into the urine from time zero to the last measured time point (fe(0-last))

Time: Day 1 and Day 57: Pre-dose and between 0-6 hours, 6-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-dose

Description: Urine PK parameters for AZD2693 full-length ASOs will be derived from the urine data

Measure: Renal clearance of drug from plasma, estimated by dividing Ae(0-t) by AUC(0-t) where the 0-t interval is the same for both Ae and AUC (CLR)

Time: Day 1 and Day 57: Pre-dose and between 0-6 hours, 6-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-dose

Purpose: Treatment

Allocation: Randomized

Sequential Assignment


There is one SNP

SNPs


1 I148M

- Provision of signed, written, and dated informed consent for mandatory Genetic PNPLA3 I148M determination genetic/biomarker, for inclusion or exclusion in the clinical study. --- I148M ---

- Mandatory PNPLA3 Genetic Biomarker and Companion Diagnostic Development Sample: - The participant will be excluded from the study if consent for the PNPLA I148M Genetic Biomarker Sample is not given. --- I148M ---

- The mandatory consent will include assessment of PNPLA3 I148M status as well as additional genotyping of gene variants associated with PNPLA3 expression. --- I148M ---



HPO Nodes


HPO: