Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03210909
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Actual Duration (Days): 28
• Patients Per Site Per Month: 5.4

Study Details

Study Description

Brief Summary

An intravenous infusion in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986231

Condition or Disease	Intervention/Treatment	Phase
Heart Decompensation, Acute	Drug: BMS-986231	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants
• Actual Study Start Date: Jun 22, 2017
• Actual Primary Completion Date: Jul 20, 2017
• Actual Study Completion Date: Jul 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986231 Intravenous Infusion A single continuous intravenous infusion of BMS-986231	Drug: BMS-986231; BMS-986231

Outcome Measures

Primary Outcome Measures

1. Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T]) [Up to 8 days]

   Measured by plasma concentrations

2. Percent of Total Radioactivity Recovered in All Excreta (% total) [Up to 8 days]

   Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts

3. Half-Life (T-HALF) [Up to 8 days]

   Measured by plasma concentrations

4. Total Body Clearance (CLT) [Up to 8 days]

   Measured by plasma concentrations

5. Volume of Distribution during Terminal Elimination Phase (Vz/F) [Up to 8 days]

   Measured by plasma concentrations

6. Time to Maximum Observed Concentration (Tmax) [Up to 8 days]

   Measured by plasma concentrations

Secondary Outcome Measures

1. Incidence of adverse events (AEs) [Up to 8 days]

   Measured by investigator assessment

2. Results of electrocardiogram tests (ECGs) [Up to 8 days]

   Measured by investigator assessment

3. Results of vital sign measurements [Up to 8 days]

   Measured by investigator assessment

4. Results of clinical laboratory tests [Up to 8 days]

   Measured by investigator assessment

Eligibility Criteria

Criteria

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

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 between 75 and 95 kg, inclusive; body mass index (BMI) between 18 to 32 kg/m2.

Exclusion Criteria:

• History of chronic illness

• Chronic headaches

• Recurrent dizziness

• Personal or family history of heart disease

• Personal history of bleeding diathesis

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03210909
• Other Study ID Numbers: CV013-022
• First Posted: Jul 7, 2017
• Last Update Posted: Aug 1, 2017
• Last Verified: Jul 1, 2017

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

Study Results

No Results Posted as of Aug 1, 2017