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

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

Study Overview

• Status: Completed
• Conditions: Heart Decompensation, Acute
• Intervention / Treatment: Drug: BMS-986231

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])	Measured by plasma concentrations	Up to 8 days
Percent of Total Radioactivity Recovered in All Excreta (% total)	Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts	Up to 8 days
Half-Life (T-HALF)	Measured by plasma concentrations	Up to 8 days
Total Body Clearance (CLT)	Measured by plasma concentrations	Up to 8 days
Volume of Distribution during Terminal Elimination Phase (Vz/F)	Measured by plasma concentrations	Up to 8 days
Time to Maximum Observed Concentration (Tmax)	Measured by plasma concentrations	Up to 8 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs)	Measured by investigator assessment	Up to 8 days
Results of electrocardiogram tests (ECGs)	Measured by investigator assessment	Up to 8 days
Results of vital sign measurements	Measured by investigator assessment	Up to 8 days
Results of clinical laboratory tests	Measured by investigator assessment	Up to 8 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2017
• Primary Completion (Actual): July 20, 2017
• Study Completion (Actual): July 20, 2017

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 28, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CV013-022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No