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Study to Assess the Effect of Acid-reducing Agent Famotidine on the Drug Levels of BMS-986256 in Healthy Participants

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 1

Conditions

Healthy Participants

Treatments

Drug: BMS-986256
Drug: Famotidine

Study type

Interventional

Funder types

Industry

Identifiers

NCT04470778
IM026-028

Details and patient eligibility

About

The purpose of this study is to investigate the effect of gastric pH changes due to famotidine administration on the drug levels of prototype BMS-986256 tablet formulation in healthy participants.

Enrollment

35 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Healthy participants having no clinically significant deviations from normal in medical history, physical examination (PE) findings, electrocardiograms (ECGs), vital signs, and clinical laboratory results that would compromise the ability to participate, complete, and/or interpret the results of the study
  • Weight ≥ 50 kg and body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2 inclusive at screening
  • Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Any significant acute or chronic medical illness
  • Any major surgery within 4 weeks of study treatment administration
  • Any other sound medical, psychiatric, and/or social reason as determined by the investigator

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

35 participants in 2 patient groups

BMS-986256
Experimental group
Treatment:
Drug: BMS-986256
BMS-986256 + Famotidine
Experimental group
Treatment:
Drug: Famotidine
Drug: BMS-986256

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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