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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BMS-986165

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Covance Madison Clinical Research Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single dose of radiolabeled BMS-986165

Arm Description

Outcomes

Primary Outcome Measures

The primary endpoint is PK exposure that will be determined from plasma concentration versus time

Urinary/fecal TRA (Total radioactivity) recovery data

PK terminal elimination half-life data (T-HALF)

PK apparent total body clearance (CL/F)

PK apparent volume of distribution (Vz/F)

PK time of maximum observed plasma concentration (Tmax)

Secondary Outcome Measures

Safety endpoints include the incidence of adverse events (AEs)

Safety endpoints include the results of electrocardiogram tests (ECGs)

Safety endpoints include the results of vital signs

Safety endpoints include the results of physical exams

Safety endpoints include the results of clinical laboratory tests

Full Information

NCT ID

NCT03004768

First Posted

December 19, 2016

Last Updated

February 8, 2018

Sponsor

Bristol-Myers Squibb

Collaborators

Covance

1. Study Identification

Unique Protocol Identification Number

NCT03004768

Brief Title

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

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

January 26, 2017 (Actual)

Primary Completion Date

February 27, 2017 (Actual)

Study Completion Date

February 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

Covance

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single dose of radiolabeled BMS-986165

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

BMS-986165

Intervention Description

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

Primary Outcome Measure Information:

Title

The primary endpoint is PK exposure that will be determined from plasma concentration versus time

Time Frame

Day 1 to Day 13

Title

Urinary/fecal TRA (Total radioactivity) recovery data

Time Frame

Day 1 to Day 13

Title

PK terminal elimination half-life data (T-HALF)

Time Frame

Day 1 to Day 13

Title

PK apparent total body clearance (CL/F)

Time Frame

Day 1 to Day 13

Title

PK apparent volume of distribution (Vz/F)

Time Frame

Day 1 to Day 13

Title

PK time of maximum observed plasma concentration (Tmax)

Time Frame

Day 1 to Day 13

Secondary Outcome Measure Information:

Title

Safety endpoints include the incidence of adverse events (AEs)

Time Frame

Day 1 to Day 13

Title

Safety endpoints include the results of electrocardiogram tests (ECGs)

Time Frame

Day 1 to Day 13

Title

Safety endpoints include the results of vital signs

Time Frame

Day 1 to Day 13

Title

Safety endpoints include the results of physical exams

Time Frame

Day 1 to Day 13

Title

Safety endpoints include the results of clinical laboratory tests

Time Frame

Day 1 to Day 13

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Covance Madison Clinical Research Unit

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53704

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.bms.com/studyconnect/pages/home.aspx

Description

BMS Clinical Trial Education Resource

URL

http://www.fda.gov/Safety/Recalls/

Description

FDA Safety Alerts and Recalls

Learn more about this trial

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

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