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

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: BMS-986165

• Registration Number: NCT03873415
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-25
• Study First Submitted: 2019-02-04
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-13
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-25
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Formulation C	BMS-986165	Dosage formulation and area of release varies between arms
Formulation D	BMS-986165	Dosage formulation and area of release varies between arms
Formulation B	BMS-986165	Dosage formulation and area of release varies between arms
Formulation A	BMS-986165	Dosage formulation and area of release varies between arms
Formulation E	BMS-986165	Dosage formulation and area of release varies between arms
Formulation F	BMS-986165	Dosage formulation and area of release varies between arms
Formulation G	BMS-986165	Dosage formulation and area of release varies between arms
Formulation H	BMS-986165	Dosage formulation and area of release varies between arms

Primary Outcome Measures

Name	Time	Method
Time of maximum observed plasma concentration (Tmax) of BMS-986165 following Treatments A, B, C, and D	Determined over 5 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986165 following Treatments A, B, C, and D	Determined over 5 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986165 following Treatments A, B, C, and D	Determined over 5 days
Maximum observed plasma concentration (Cmax) of BMS-986165 following Treatments A, B, C, and D	Determined over 5 days
Apparent plasma elimination half-life (T-HALF) of BMS-986165 following Treatments A, B, C, and D	Determined over 5 days

Secondary Outcome Measures

Name	Time	Method
Physical examination	Up to 60 days
Pulse rate	Up to 60 days
Vital signs of body temperature	Up to 60 days
Vital sign of respiratory rate	Up to 60 days
Vital sign of supine blood pressure	Up to 60 days
Incidence of adverse events (AE)	Up to 90 days
Incidence of serious adverse events (SAE)	Up to 90 days

Trial Locations

Locations (1)

Scintipharma; 🇺🇸 Lexington, Kentucky, United States