Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Thrombosis

Treatments: Drug: BMS-986177

Study type: Interventional

Funder types: Industry

Identifiers

NCT03939702

CV010-036

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

9 participants in 2 patient groups

Non-Bile Collection

Active Comparator group

Description:

On Day 1, all participants will receive a single oral solution dose of 200 mg \[14C\] BMS-986177 containing approximately 88 micro Ci of total radioactivity (TRA). Participants will remain in the clinical facility until at least Day 7 and will be discharged when release criteria are met or until Day 12

Treatment:

Drug: BMS-986177

Bile Collection

Active Comparator group

Description:

On Day 1, all participants will receive a single oral solution dose of 200 mg \[14C\] BMS-986177 containing approximately 88 micro Ci of total radioactivity (TRA). Approximately 1 hour after study drug administration, an ND tube may be positioned in approximately 3 selected participants for collection of bile.Participants will remain in the clinical facility until at least Day 7 and will be discharged when release criteria are met or until Day 12

Treatment:

Drug: BMS-986177