Pharmacokinetics and Metabolism Study of Radiolabeled BMS-986142 in Healthy Male Subjects

Phase 1

Completed

• Conditions: Arthritis
• Interventions: Drug: BMS-986142

• Registration Number: NCT02880670
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

This is an open-label, single-dose, study in healthy males. The primary objective is to assess the pharmacokinetics (PK), metabolism, and routes of elimination of a single oral dose of radiolabeled BMS-986142 in healthy male subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-26
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-15
• Last Update Posted: 2016-11-16

Recruitment & Eligibility

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

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.

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, or 30 days after the last dose of study drug.
• 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.
• History of allergies and adverse drug reaction to any oral contraceptive compounds or Bruton tyrosine kinase (BTK) inhibitors.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single dose of radiolabeled BMS-986142	BMS-986142	-

Primary Outcome Measures

Name	Time	Method
The primary endpoint is PK parameters that will be determined from plasma concentration versus time	Day 1 to Day 13
Urinary/fecal/bile (if applicable) TRA (Total radioactivity) recovery data	Day 1 to Day 13

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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