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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Famotidine; Drug: Pegasys; Drug: BMS-986465; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06144697

CN009-1024

Details and patient eligibility

About

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.

Enrollment: 267 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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267 participants in 4 patient groups

Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo]

Experimental group

Treatment:

Other: Placebo

Drug: BMS-986465

Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys]

Experimental group

Treatment:

Other: Placebo

Drug: BMS-986465

Drug: Pegasys

Part C: MAD in Japanese ethnicity [BMS-986465 or placebo]

Experimental group

Treatment:

Other: Placebo

Drug: BMS-986465

Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine]

Experimental group

Treatment:

Drug: BMS-986465

Drug: Famotidine