SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT03292302

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 1a, Randomized, Double-blinded, Placebo-Controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ELX-02 in Healthy Adult Volunteers

Phase 1 Single Ascending Dose Study in Normal Healthy Volunteers

NCT03292302 Genetic Disease Nonsense Mutation
MeSH:Genetic Diseases, Inborn

2 Interventions

Name: Placebo

Description: Placebo comparator
Type: Drug
Group Labels: 1

Placebo Comparator Arm

Name: ELX-02

Description: Synthetic aminoglycoside
Type: Drug
Group Labels: 1

Active treatment


Primary Outcomes

Description: Incidence and characteristics of adverse events occurring following single doses of ELX-02

Measure: Adverse Events

Time: 0-10 days

Description: Cmax will be determined for ELX-02 and an estimation of ELX-02 dose proportionality of PK parameters.

Measure: Pharmacokinetics: Maximum plasma concentration (Cmax)

Time: 0-10 days

Description: tmax will be determined for ELX-02 and an estimation of ELX-02 dose proportionality of PK parameters.

Measure: Pharmacokinetics: Time at which Cmax occurs (tmax)

Time: 0-10 days

Description: AUC24h will be determined for ELX-02 and an estimation of ELX-02 dose proportionality of PK parameters.

Measure: Pharmacokinetics: Area under the plasma concentration-time curve calculated from time of administration to time 24h (AUC24h)

Time: 0-10 days

Description: AUC48h will be determined for ELX-02 and an estimation of ELX-02 dose proportionality of PK parameters.

Measure: Pharmacokinetics: Area under the plasma concentration-time curve calculated from time of administration to time 48h (AUC48h)

Time: 0-10 days

Description: AUCinf will be determined for ELX-02 and an estimation of ELX-02 dose proportionality of PK parameters.

Measure: Pharmacokinetics: Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)

Time: 0-10 days

Description: MRT will be determined for ELX-02 and an estimation of ELX-02 dose proportionality of PK parameters.

Measure: Pharmacokinetics: Mean residence time (MRT)

Time: 0-10 days

Description: t1/2 will be determined for ELX-02 and an estimation of ELX-02 dose proportionality of PK parameters.

Measure: Pharmacokinetics: Elimination half-life (t1/2)

Time: 0-10 days

Description: Vd/F will be determined for ELX-02 and an estimation of ELX-02 dose proportionality of PK parameters.

Measure: Pharmacokinetics: Volume of distribution (Vd/F)

Time: 0-10 days

Description: CL/F will be determined for ELX-02 and an estimation of ELX-02 dose proportionality of PK parameters.

Measure: Pharmacokinetics: Clearance (CL/F)

Time: 0-10 days

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 4 SNPs

SNPs


1 A1555G

4. Presence of mitochondrial mutations making subject susceptible to aminoglycoside toxicity (A1555G, C1494T, T1095C, A827G, 1-BP DEL, 961T, C INS). 5. Subjects with any history of ear disease or surgeries, persistent dizziness or persistent tinnitus. --- A1555G ---


2 A827G

4. Presence of mitochondrial mutations making subject susceptible to aminoglycoside toxicity (A1555G, C1494T, T1095C, A827G, 1-BP DEL, 961T, C INS). 5. Subjects with any history of ear disease or surgeries, persistent dizziness or persistent tinnitus. --- A1555G --- --- C1494T --- --- T1095C --- --- A827G ---


3 C1494T

4. Presence of mitochondrial mutations making subject susceptible to aminoglycoside toxicity (A1555G, C1494T, T1095C, A827G, 1-BP DEL, 961T, C INS). 5. Subjects with any history of ear disease or surgeries, persistent dizziness or persistent tinnitus. --- A1555G --- --- C1494T ---


4 T1095C

4. Presence of mitochondrial mutations making subject susceptible to aminoglycoside toxicity (A1555G, C1494T, T1095C, A827G, 1-BP DEL, 961T, C INS). 5. Subjects with any history of ear disease or surgeries, persistent dizziness or persistent tinnitus. --- A1555G --- --- C1494T --- --- T1095C ---



HPO Nodes