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

NCT03004768 | Completed Phase 1 FDA Drug

• 1 other identifier: IM011-016
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• 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

Study Arms (1)

Single dose of radiolabeled BMS-986165

EXPERIMENTAL

Drug: BMS-986165

Interventions

BMS-986165 DRUG

Oral solution dose of 24 mg \[14C\] BMS-986165 containing approximately 100 micro Ci of TRA

Single dose of radiolabeled BMS-986165

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Covance: collaborator

Study Sites (1)

Covance Madison Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Related Links

• BMS Clinical Trial Education Resource
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Psoriasis

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 29, 2016
• Study Start: January 26, 2017
• Primary Completion: February 27, 2017
• Study Completion: February 27, 2017
• Last Updated: February 12, 2018

Record last verified: 2018-02

Locations

US (1)