Pharmacokinetics (Drug Levels in Blood) of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: BMS-986165; Drug: BMS-986165 prototype 1; Drug: BMS-986165 prototype 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT04249284

IM011-096

Details and patient eligibility

About

The purpose of this study is to characterize the pharmacokinetics (the way the body absorbs, distributes and eliminates the drug) of BMS 986165 given in the form of various prototypes of solid tablets to healthy participants.

Enrollment: 18 patients

Sex: All

Ages: 18 to 45 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:

• In the opinion of the investigator, a healthy participant is determined by having no clinically significant deviation from normal in medical history, physical examination,electrocardiograms, vital signs, and clinical laboratory determinations.
• Body weight >= 50 kg at screening
• Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

• Any major surgery, per investigator's discretion, within 4 weeks of study drug administration
• Inability to tolerate oral medication
• History of allergy to BMS-986165 or related compounds

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 4 patient groups

Treatment A : BMS-986165

Experimental group

Treatment:

Drug: BMS-986165

Treatment B: BMS-986165 prototype 1

Experimental group

Treatment:

Drug: BMS-986165 prototype 1

Treatment C: BMS-986165 prototype 2

Experimental group

Treatment:

Drug: BMS-986165 prototype 2

Treatment D: BMS-986165 prototype 2

Experimental group

Treatment:

Drug: BMS-986165 prototype 2