Assessment of Gut Absorption of Experimental Medication BMS-986165 in Healthy Males

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Psoriasis

Treatments: Drug: BMS-986165

Study type: Interventional

Funder types: Industry

Identifiers

NCT03873415

IM011-019

Details and patient eligibility

About

The purpose of this study is to evaluate sites of gut absorption of BMS-986165 in males

Enrollment: 9 patients

Sex: Male

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:

• Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
• Estimated glomerular filtration rate (eGFR) > 80 mL/min/1.732 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) disease of the gut that, in the opinion of the Investigator or Medical Monitor, could impact upon the absorption of study drug
• Acute diarrhea, or constipation within 3 weeks prior to randomization
• Any major surgery within 4 weeks of randomization

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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9 participants in 8 patient groups

Formulation A

Experimental group

Description:

Dosage formulation and area of release varies between arms

Treatment:

Drug: BMS-986165

Formulation B

Experimental group

Description:

Dosage formulation and area of release varies between arms

Treatment:

Drug: BMS-986165

Formulation C

Experimental group

Description:

Dosage formulation and area of release varies between arms

Treatment:

Drug: BMS-986165

Formulation D

Experimental group

Description:

Dosage formulation and area of release varies between arms

Treatment:

Drug: BMS-986165

Formulation E

Experimental group

Description:

Dosage formulation and area of release varies between arms

Treatment:

Drug: BMS-986165

Formulation F

Experimental group

Description:

Dosage formulation and area of release varies between arms

Treatment:

Drug: BMS-986165

Formulation G

Experimental group

Description:

Dosage formulation and area of release varies between arms

Treatment:

Drug: BMS-986165

Formulation H

Experimental group

Description:

Dosage formulation and area of release varies between arms

Treatment:

Drug: BMS-986165