A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Afimetoran; Drug: Famotidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05866627

1007296 (Other Identifier)

IM026-1023

Details and patient eligibility

About

The purpose of this study is to confirm there is no significant effect of gastric pH changes of famotidine on the drug levels of afimetoran in healthy participants.

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Weight ≥ 50 kilograms (kg), at screening and first admission, and body mass index between 18.0 kilogram per square meter (kg/m^2) and 32.0 kg/m^2, inclusive, at screening.
• A negative QuantiFERON-TB Gold test result at screening or documentation of a negative result within 3 months before screening.
• Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 milliliter per minute (mL/min)/1.732 m^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.

Exclusion criteria

• Any significant acute or chronic medical illness.
• Current or recent (within 3 months of study drug administration) gastrointestinal (GI) disease that could impact upon the absorption of study treatment.
• GI surgery, including cholecystectomy, that could impact upon the absorption of study treatment, at the investigator's discretion.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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76 participants in 4 patient groups

Afimetoran, followed by famotidine + afimetoran

Experimental group

Treatment:

Drug: Famotidine

Drug: Afimetoran

Famotidine + afimetoran, followed by afimetoran

Experimental group

Treatment:

Drug: Famotidine

Drug: Afimetoran

Afimetoran

Experimental group

Treatment:

Drug: Afimetoran

Famotidine, followed by afimetoran

Experimental group

Treatment:

Drug: Famotidine

Drug: Afimetoran