Clinical trial NCT03939702: Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants
Official title: Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thrombosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-05-07
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is an ADME study. Human radiolabeled mass balance studies are performed as part of drug development to obtain information about the absorption, distribution, metabolism, and excretion (ADME) of a study treatment. The goals of human ADME studies include the assessment of absorption, distribution, routes and rates of excretion, mass balance, and metabolite profile and identification.


Eligibility criteria: Inclusion Criteria:

* Signed ICF
* Healthy Male
* Body mass index of 18.0 to 32.0 kg/m2, inclusive.
* Agreement to use approved contraception for 94 days post treatment
* Agreement to not donate sperm for 94 days post treatment

Exclusion Criteria:

* Acute or chronic illness
* GI disease current or recent
* History of dizziness or recurring headaches
* Head injury within last 2 years
* GI surgery
* History or evidence of abnormal bleeding

Primary outcomes:
measure: Assess PK Cmax of a dose of [14C]BMS-986177
timeFrame: Day 1-12
measure: Assess PK AUC(INF) of a dose of [14C]BMS-986177
timeFrame: Day 1-12
measure: Assess PK AUC(0-T) of a dose of [14C]BMS-986177
timeFrame: Day 1-12
measure: Assess PK Tmax of a dose of [14C]BMS-986177
timeFrame: Day 1-12
measure: Assess PK T-HALF of a dose of [14C]BMS-986177
timeFrame: Day 1-12
measure: Assess PK CL/F of a dose of [14C]BMS-986177
timeFrame: Day 1-12
measure: Assess PK Vz/F of a dose of [14C]BMS-986177
timeFrame: Day 1-12
measure: Assess PK AUC of a dose of [14C]BMS-986177
timeFrame: Day 1-12
measure: Assess PK AUC(TRA) of a dose of [14C]BMS-986177
timeFrame: Day 1-12
measure: Assess PK Plasma AUC(TRA) of a dose of [14C]BMS-986177
timeFrame: Day 1-12
measure: Assess PK Blood AUC(TRA) of a dose of [14C]BMS-986177
timeFrame: Day 1-12
measure: Assess the CLR of [14C]BMS-986177
timeFrame: Day 1-12
measure: Assess the %UR of [14C]BMS-986177
timeFrame: Day 1-12
measure: Assess the %FE of [14C]BMS-986177
timeFrame: Day 1-12
measure: Assess the %BE of [14C]BMS-986177
timeFrame: Day 1-12
measure: Assess the %Total recovery of [14C]BMS-986177
timeFrame: Day 1-12
Secondary outcomes:
measure: Asess the Incidence of AEs of a single oral dose of 200 mg [14C] BMS-986177
timeFrame: Day 1-12
measure: Asess the Incidence of SAEs of a single oral dose of 200 mg [14C] BMS-986177
timeFrame: Day 1-12
measure: Asess the Incidence of AEs leading to discontinuation of a single oral dose of 200 mg [14C] BMS-986177
timeFrame: Day 1-12
measure: Assess the vital signs of a subject dosed with single oral dose of 200 mg [14C] BMS-986177
timeFrame: Day 1-12
measure: Assess the ECGs of subjects dosed with single oral dose of 200 mg [14C] BMS-986177
timeFrame: Day 1-12
measure: Assess the clinical lab tests of a single oral dose of 200 mg [14C] BMS-986177
timeFrame: Day 1-12
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Wisconsin
Study officials:
References: