A Study Comparing the Effects of Famotidine Pretreatment and of Food on the Relative Bioavailability of BMS-986165 in Healthy Volunteers

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Famotidine; Drug: BMS-986165

Study type: Interventional

Funder types: Industry

Identifiers

NCT04209699

IM011-119

Details and patient eligibility

About

The primary purpose of this study is to evaluate the effects of food and pH on the relative bioavailability (BA) of the tablet formulation of BMS-986165 in healthy volunteers

Enrollment: 18 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:

• Body mass index of 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, and body weight ≥ 50 kg, at screening
• Male and female paritcipants, aged 18 years, or age of majority, to age 55 years, inclusive
• All female subjects must have a negative serum or urine pregnancy test

Exclusion Criteria:

• Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease.
• History of administration of live vaccines within 60 days before screening until clinic discharge
• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population

Other protocol-defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Treatment A: BMS-986165 alone, fasted

Experimental group

Treatment:

Drug: BMS-986165

Treatment B: BMS-986165 alone, fed

Experimental group

Treatment:

Drug: BMS-986165

Treatment C: BMS-986165 with famotidine pretreatment, fasted

Experimental group

Treatment:

Drug: BMS-986165

Drug: Famotidine