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NCT06144697 | TERMINATED | Healthy Participants

A Study to Evaluate the Safety, Tolerability, Drug Levels, Food, Formulation, and pH Effects on Relative Absorption of BMS-986465 and Its Active Derivative BMS-986464 in Healthy Participants
Sponsor:

Bristol-Myers Squibb

Brief Summary:

The purpose of this study is to evaluate safety, tolerability, drug and food effects on relative bioavailability of BMS-986465 and its active derivative BMS-986464 in healthy participants and healthy participants of Japanese ethnicity.

Condition or disease

Healthy Participants

Intervention/treatment

BMS-986465

Placebo

Pegasys

Famotidine

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 267 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Prodrug BMS-986465 and Its Active Derivative, BMS-986464, in Healthy Participants Including Healthy Participants of Japanese Ethnicity and an Open-label Assessment of Food, Formulation, and pH Effects on the Relative Bioavailability of BMS-986465 and BMS-986464
Actual Study Start Date : 2024-01-29
Estimated Primary Completion Date : 2024-10-16
Estimated Study Completion Date : 2024-10-16

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * Healthy male and female (i e, women not of childbearing potential) participants
  • * Body Mass Index (BMI) of 18 to 32 kg\^m2 and total body weight ≥ 50 kg
  • * Parts A, B, and D: Participants without restriction on ethnicity
  • * Part C: Participants of Japanese ethnicity (both biological parents are ethnically Japanese)
Exclusion Criteria
  • * Clinically significant medical, psychiatric and/or sound social reason, as determined by the investigator
  • * Any major surgery within 3 months of study intervention administration
  • * Participation in another clinical trial concurrent with this study
  • Note: Other protocol-defined inclusion/exclusion criteria apply
A Study to Evaluate the Safety, Tolerability, Drug Levels, Food, Formulation, and pH Effects on Relative Absorption of BMS-986465 and Its Active Derivative BMS-986464 in Healthy Participants

Location Details

NCT06144697

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Local Institution - 0001

Anaheim, California, United States, 92801

Not yet recruiting

United States, Texas

Local Institution - 0003

Austin, Texas, United States, 78744