Clinical trial NCT03004768: Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants
Official title: Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Covance
First posted: 2016-12-29
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: The primary endpoint is PK exposure that will be determined from plasma concentration versus time
timeFrame: Day 1 to Day 13
measure: Urinary/fecal TRA (Total radioactivity) recovery data
timeFrame: Day 1 to Day 13
measure: PK terminal elimination half-life data (T-HALF)
timeFrame: Day 1 to Day 13
measure: PK apparent total body clearance (CL/F)
timeFrame: Day 1 to Day 13
measure: PK apparent volume of distribution (Vz/F)
timeFrame: Day 1 to Day 13
measure: PK time of maximum observed plasma concentration (Tmax)
timeFrame: Day 1 to Day 13
Secondary outcomes:
measure: Safety endpoints include the incidence of adverse events (AEs)
timeFrame: Day 1 to Day 13
measure: Safety endpoints include the results of electrocardiogram tests (ECGs)
timeFrame: Day 1 to Day 13
measure: Safety endpoints include the results of vital signs
timeFrame: Day 1 to Day 13
measure: Safety endpoints include the results of physical exams
timeFrame: Day 1 to Day 13
measure: Safety endpoints include the results of clinical laboratory tests
timeFrame: Day 1 to Day 13
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Madison Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: