A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Lupus

Treatments: Drug: BMS-986165 Tablet; Drug: Famotidine; Drug: BMS-986165-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT04065932

IM011-020

Details and patient eligibility

About

A Study to Determine the Drug Level Profile of Different formulations of BMS-986165 Tablets

Enrollment: 33 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:

• Patients must be willing and able to complete all study-specific procedures and visits
• Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations
• Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
• Normal renal function at screening

Exclusion Criteria:

• History or presence of chronic bacterial, viral infection, or autoimmune disorder
• Active TB requiring treatment or documented latent TB within the previous 3 years
• Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
• WOCBP (women of childbearing potential) must have negative serum or urine pregnancy test.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 6 patient groups

BMS-985165-01 prototype formulation 1

Experimental group

Treatment:

Drug: BMS-986165-01

BMS-986165 Tablet

Experimental group

Treatment:

Drug: BMS-986165 Tablet

BMS-985165-01 prototype formulation 2

Experimental group

Treatment:

Drug: BMS-986165-01

BMS-985165-01 prototype formulation 3

Experimental group

Treatment:

Drug: BMS-986165-01

BMS-985165-01 prototype formulation 3 or 4

Experimental group

Treatment:

Drug: BMS-986165-01

Drug: Famotidine

BMS-985165-01 prototype formulation 3, 4 or 5

Experimental group

Treatment:

Drug: BMS-986165-01

Drug: Famotidine