A Phase 1, Two-Part, Double-blind, Placebo-controlled, Randomized Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986278 (Part A) and a Randomized, Double-blind, Positive-controlled, Placebo-controlled, 4-Period Crossover, Thorough QT/QTc Study to Evaluate the Effect of Multiple Doses of BMS-986278 on Cardiac Repolarization (Part B) in Healthy Participants
Abstract
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) of high dose of BMS-986278 in healthy participants and to assess the effect of BMS-986278 on the ECG intervals in healthy participants.
Conditions: Healthy Volunteers.
Primary outcome: Number of participants with non-serious Adverse Events (AEs); Number of participants with Serious AEs (SAEs); Number of participants with AEs leading to study intervention discontinuation; Number of participants with vital sign abnormalities; Number of participants with clinical laboratory assessment abnormalities; Number of participants with 12-lead electrocardiogram (ECG) abnormalities; Number of participants with physical examination abnormalities; Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF); Placebo-corrected change from baseline QTcF (ΔΔQTcF).
Enrollment: 42 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 42 participants or records.
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