Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants

Phase 1

Completed

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

• Registration Number: NCT03004768
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

An oral dose in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986165

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2016-12-23
• Study First Posted: 2016-12-29
• Study Start: 2017-01-26
• Primary Completion: 2017-02-27
• Study Completion: 2017-02-27
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-08
• Last Update Posted: 2018-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

• Signed Informed Consent
• Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
• Body weight of at least 50 kilograms (110 pounds); body mass index (BMI) between 18 to 32 kg/m2.
• No evidence of acute infection or other significant problem as determined from a review of a chest x-ray, medical history, and physical examination

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Exclusion Criteria

• History of any chronic or acute illness including active TB in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured.
• Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study
• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population.
• Participant with greater than Grade 2 acne.
• Participated in a radiolabeled drug study within the previous 12 months; clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months; or current employment in a job requiring radiation exposure monitoring.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single dose of radiolabeled BMS-986165	BMS-986165	-

Primary Outcome Measures

Name	Time	Method
The primary endpoint is PK exposure that will be determined from plasma concentration versus time	Day 1 to Day 13
Urinary/fecal TRA (Total radioactivity) recovery data	Day 1 to Day 13
PK time of maximum observed plasma concentration (Tmax)	Day 1 to Day 13
PK terminal elimination half-life data (T-HALF)	Day 1 to Day 13
PK apparent total body clearance (CL/F)	Day 1 to Day 13
PK apparent volume of distribution (Vz/F)	Day 1 to Day 13

Secondary Outcome Measures

Name	Time	Method
Safety endpoints include the incidence of adverse events (AEs)	Day 1 to Day 13
Safety endpoints include the results of electrocardiogram tests (ECGs)	Day 1 to Day 13
Safety endpoints include the results of vital signs	Day 1 to Day 13
Safety endpoints include the results of physical exams	Day 1 to Day 13
Safety endpoints include the results of clinical laboratory tests	Day 1 to Day 13

Trial Locations

Locations (1)

Covance Madison Clinical Research Unit; 🇺🇸 Madison, Wisconsin, United States