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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03939702
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.3
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thrombosis	Drug: BMS-986177	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants
• Actual Study Start Date: May 2, 2019
• Actual Primary Completion Date: Jul 11, 2019
• Actual Study Completion Date: Jul 11, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Non-Bile Collection 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	Drug: BMS-986177; An orally administered anticoagulant to prevent and treat thromboembolic events
Active Comparator: Bile Collection 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	Drug: BMS-986177; An orally administered anticoagulant to prevent and treat thromboembolic events

Outcome Measures

Primary Outcome Measures

1. Assess PK Cmax of a dose of [14C]BMS-986177 [Day 1-12]

   Cmax

2. Assess PK AUC(INF) of a dose of [14C]BMS-986177 [Day 1-12]

   AUC(INF)

3. Assess PK AUC(0-T) of a dose of [14C]BMS-986177 [Day 1-12]

   AUC(0-T)

4. Assess PK Tmax of a dose of [14C]BMS-986177 [Day 1-12]

   Tmax

5. Assess PK T-HALF of a dose of [14C]BMS-986177 [Day 1-12]

   T-HALF

6. Assess PK CL/F of a dose of [14C]BMS-986177 [Day 1-12]

7. Assess PK Vz/F of a dose of [14C]BMS-986177 [Day 1-12]

   Vz/F

8. Assess PK AUC of a dose of [14C]BMS-986177 [Day 1-12]

   AUC(BMS-986177)

9. Assess PK AUC(TRA) of a dose of [14C]BMS-986177 [Day 1-12]

   AUC(TRA)

10. Assess PK Plasma AUC(TRA) of a dose of [14C]BMS-986177 [Day 1-12]

    Plasma AUC(TRA)

11. Assess PK Blood AUC(TRA) of a dose of [14C]BMS-986177 [Day 1-12]

    Blood AUC(TRA)

12. Assess the CLR of [14C]BMS-986177 [Day 1-12]

    CLR

13. Assess the %UR of [14C]BMS-986177 [Day 1-12]

    %UR

14. Assess the %FE of [14C]BMS-986177 [Day 1-12]

    %FE

15. Assess the %BE of [14C]BMS-986177 [Day 1-12]

    %BE (if applicable)

16. Assess the %Total recovery of [14C]BMS-986177 [Day 1-12]

    %Total recovery

Secondary Outcome Measures

1. Asess the Incidence of AEs of a single oral dose of 200 mg [14C] BMS-986177 [Day 1-12]

   Incidence of AEs

2. Asess the Incidence of SAEs of a single oral dose of 200 mg [14C] BMS-986177 [Day 1-12]

   Incidence of SAEs

3. Asess the Incidence of AEs leading to discontinuation of a single oral dose of 200 mg [14C] BMS-986177 [Day 1-12]

   Incidence of AEs leading to discontinuation

4. Assess the vital signs of a subject dosed with single oral dose of 200 mg [14C] BMS-986177 [Day 1-12]

   results of vital sign examination

5. Assess the ECGs of subjects dosed with single oral dose of 200 mg [14C] BMS-986177 [Day 1-12]

   ECG physical examinations

6. Assess the clinical lab tests of a single oral dose of 200 mg [14C] BMS-986177 [Day 1-12]

   Results of Clinical laboratory tests

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research Unit, Inc.	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03939702
• Other Study ID Numbers: CV010-036
• First Posted: May 7, 2019
• Last Update Posted: Oct 4, 2019
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thrombosis

Study Results

No Results Posted as of Oct 4, 2019