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

Bristol-Myers Squibb (BMS) logo

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)

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

Trial contacts and locations

1

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Central trial contact

First line of the email MUST contain the NCT# and Site #.; BMS Study Connect Contact Center www.BMSStudyConnect.com

Data sourced from clinicaltrials.gov

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