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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03004768
• Other study ID #: IM011-016
• Status: Completed
• Phase: Phase 1
• First received: December 19, 2016
• Last updated: February 8, 2018
• Start date: January 26, 2017
• Est. completion date: February 27, 2017

Study information

• Verified date: February 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 27, 2017
• Est. primary completion date: February 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
United States	Covance Madison Clinical Research Unit	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Covance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is PK exposure that will be determined from plasma concentration versus time		Day 1 to Day 13
Primary	Urinary/fecal TRA (Total radioactivity) recovery data		Day 1 to Day 13
Primary	PK terminal elimination half-life data (T-HALF)		Day 1 to Day 13
Primary	PK apparent total body clearance (CL/F)		Day 1 to Day 13
Primary	PK apparent volume of distribution (Vz/F)		Day 1 to Day 13
Primary	PK time of maximum observed plasma concentration (Tmax)		Day 1 to Day 13
Secondary	Safety endpoints include the incidence of adverse events (AEs)		Day 1 to Day 13
Secondary	Safety endpoints include the results of electrocardiogram tests (ECGs)		Day 1 to Day 13
Secondary	Safety endpoints include the results of vital signs		Day 1 to Day 13
Secondary	Safety endpoints include the results of physical exams		Day 1 to Day 13
Secondary	Safety endpoints include the results of clinical laboratory tests		Day 1 to Day 13

External Links

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