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Report for Clinical Trial NCT02391623
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary
purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
multiple oral doses of PF-06427878 in healthy adult subjects.
NCT02391623 Healthy Subjects
4 Interventions
Name: PF-06427878
Description: PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Type: Drug
Group Labels: 5 Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5
Name: Placebo
Description: Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
Type: Drug
Group Labels: 5 Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5
Name: PF-06427878
Description: PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Type: Drug
Name: Placebo
Description: Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
Type: Drug
Primary Outcomes
Measure: Assessment of adverse events (AEs). Time: 0-25 days
Measure: Assessment of clinical laboratory tests. Time: 0-25 days
Measure: Assessment of vital signs (including blood pressure and pulse rate). Time: 0-25 days
Measure: Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG). Time: 0-25 days
Secondary Outcomes
Measure: Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1 Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Measure: Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12 Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Measure: Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14 Time: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose
Measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1 Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12 Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Measure: Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1 Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Measure: Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12 Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Measure: Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Measure: Plasma Decay Half-Life (t1/2) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Measure: Apparent Volume of Distribution (Vz/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Measure: Apparent Oral Clearance (CL/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Measure: Minimum Observed Plasma Concentration (Cmin) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Measure: Peak:Trough ratio of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Measure: Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 Time: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose
Measure: Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Measure: Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day14 relative to day 1 Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Measure: Amount of PF-06427878 excreted in urine (Ae) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 Time: 0- tau hours post dose
Measure: Percent of dose excreted in urine as PF-06427878 (Ae%) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 Time: 0- tau hours post dose
Measure: Renal clearance of PF-06427878 (CLr) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 Time: 0- tau hours post dose
Purpose: Basic Science
Allocation: Randomized
There is one SNP
SNPs
Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1. null. --- Q12H ---
Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12. null. --- Q12H ---
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1. null. --- Q12H ---
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12. null. --- Q12H ---
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---
Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1. null. --- Q12H ---
Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12. null. --- Q12H ---
Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---
Plasma Decay Half-Life (t1/2) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---
Apparent Volume of Distribution (Vz/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---
Apparent Oral Clearance (CL/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---
Minimum Observed Plasma Concentration (Cmin) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---
Peak:Trough ratio of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD. --- Q12H ---
Amount of PF-06427878 excreted in urine (Ae) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---
Percent of dose excreted in urine as PF-06427878 (Ae%) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---
Renal clearance of PF-06427878 (CLr) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---