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Report for Clinical Trial NCT02145234
 Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene 
      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 
  2  Interventions 
 Name: BMS-986089
 Type: Drug
Group Labels:  12  MAD Panel 1:BMS-986089/Placebo  MAD Panel 2:BMS-986089/Placebo  MAD Panel 3:BMS-986089/Placebo  MAD Panel 4:BMS-986089/Placebo  MAD Panel 5:BMS-986089/Placebo  MAD Panel 6:BMS-986089/Placebo  MAD Panel 7:BMS-986089/Placebo  SAD Panel 1:BMS-986089/Placebo  SAD Panel 2:BMS-986089/Placebo  SAD Panel 3:BMS-986089/Placebo  SAD Panel 4:BMS-986089/Placebo  SAD Panel 5:BMS-986089/Placebo   
 Name: Placebo matching with BMS-986089
 Type: Drug
Group Labels:  12  MAD Panel 1:BMS-986089/Placebo  MAD Panel 2:BMS-986089/Placebo  MAD Panel 3:BMS-986089/Placebo  MAD Panel 4:BMS-986089/Placebo  MAD Panel 5:BMS-986089/Placebo  MAD Panel 6:BMS-986089/Placebo  MAD Panel 7:BMS-986089/Placebo  SAD Panel 1:BMS-986089/Placebo  SAD Panel 2:BMS-986089/Placebo  SAD Panel 3:BMS-986089/Placebo  SAD Panel 4:BMS-986089/Placebo  SAD Panel 5:BMS-986089/Placebo   
  
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 days
 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: 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 120
 Measure: 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
 
Purpose: Other
Allocation: Randomized
Single Group Assignment 
There is one SNP
SNPs
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 ---