SNPMiner Trials (Home Page)
Report for Mutation C168H
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 A Randomized, Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of single and multiple doses of BMS-986089 in healthy adult subjects.
NCT02145234 Healthy Adults Drug: BMS-986089 Drug: Placebo matching with BMS-986089
C(168H) Accumulation Index; ratio of C168H at steady-state to C168H after the first dose (AI C168H) for MAD. --- C168H ---
C(168H) Accumulation Index; ratio of C168H at steady-state to C168H after the first dose (AI C168H) for MAD. --- C168H --- --- C168H ---
C(168H) Accumulation Index; ratio of C168H at steady-state to C168H after the first dose (AI C168H) for MAD. --- C168H --- --- C168H --- --- C168H ---
Primary Outcomes
Measure: Safety endpoints, including incidence of Adverse Event (AEs), serious AEs, AEs leading to discontinuation or death, as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical examinations Time: Single Ascending Dose (SAD) Phase 119 daysMeasure: Safety endpoints, including incidence of Adverse Event (AEs), serious AEs, AEs leading to discontinuation or death, as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical examinations Time: Multiple Ascending Dose (MAD) phase 148 days
Secondary Outcomes
Measure: Maximum observed serum concentration (Cmax) for SAD and MAD Time: SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120Measure: Time of maximum observed serum concentration (Tmax) for SAD and MAD Time: SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120
Measure: Serum concentration 168 h post dose (C(168H)) for SAD and MAD Time: SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120
Measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) for SAD Time: SAD phase: Day1 to Day 91
Measure: Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) for SAD Time: SAD phase: Day1 to Day 91
Measure: Apparent total body clearance (CLT/F) for SAD Time: SAD phase: Day1 to Day 91
Measure: Volume of distribution of terminal phase (if IV and if multi-exponential decline) (Vz/F) for SAD Time: SAD phase: Day1 to Day 91
Measure: Half life (T-Half) for SAD and MAD Time: SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120
Measure: Serum concentration 336 h post dose (C(336H)) for SAD and MAD Time: SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120
Measure: Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) for MAD Time: MAD phase: Day 1 to Day 120
Measure: Area under the concentration-time curve in one dosing interval (AUC(TAU)) for MAD Time: MAD phase: Day 1 to Day 120
Measure: Degree of Fluctuation or Fluctuation Index (DF) for MAD Time: MAD phase: Day 1 to Day 120
Measure: Average concentration over a dosing interval (Css-Avg) for MAD Time: MAD phase: Day 1 to Day 120
Measure: AUC Accumulation Index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI AUC) for MAD Time: MAD phase: Day 1 to Day 120
Measure: Cmax Accumulation Index; ratio of Cmax at steady-state to Cmax after the first dose (AI Cmax) for MAD Time: MAD phase: Day 1 to Day 120
Measure: C(168H) Accumulation Index; ratio of C168H at steady-state to C168H after the first dose (AI C168H) for MAD Time: MAD phase: Day 1 to Day 120
Measure: C(336H) Accumulation Index; ratio of C(336H) at steady-state to C(336H) after the first dose (AI 336H) for MAD Time: MAD phase: Day 1 to Day 120
Measure: Immunogenicity of single and multiple doses of BMS-986089 will be measured by testing for the presence of ADAs for SAD and MAD Time: 30 days
Measure: The pharmacodynamic effect of single and multiple doses of BMS-986089 on free myostatin, total myostatin (pre-dose only), and myostatin-drug complex will be assessed by measuring these biomarkers for SAD and MAD Time: 30 days