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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: BMS-986165

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Madison Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single dose of radiolabeled BMS-986165	Drug: BMS-986165; Oral solution dose of 24 mg [14C] BMS-986165 containing approximately 100 micro Ci of TRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 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
PK time of maximum observed plasma concentration (Tmax)	Day 1 to Day 13

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Covance

Publications and helpful links

Helpful Links

• BMS Clinical Trial Education Resource
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2017
• Primary Completion (Actual): February 27, 2017
• Study Completion (Actual): February 27, 2017

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: December 23, 2016
• First Posted (Estimate): December 29, 2016

Study Record Updates

• Last Update Posted (Actual): February 12, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; BMS-986165
• Other Study ID Numbers: IM011-016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No