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Report for Clinical Trial NCT02145234

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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


1 C168H

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 ---



HPO Nodes