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

Heart Decompensation, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03210909
• Other study ID #: CV013-022
• Status: Completed
• Phase: Phase 1
• First received: July 5, 2017
• Last updated: July 28, 2017
• Start date: June 22, 2017
• Est. completion date: July 20, 2017

Study information

• Verified date: July 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 20, 2017
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Decompensation, Acute
• Heart Failure

Intervention

Drug:
• BMS-986231
BMS-986231

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Half-Life (T-HALF)	Measured by plasma concentrations	Up to 8 days
Primary	Total Body Clearance (CLT)	Measured by plasma concentrations	Up to 8 days
Primary	Volume of Distribution during Terminal Elimination Phase (Vz/F)	Measured by plasma concentrations	Up to 8 days
Primary	Time to Maximum Observed Concentration (Tmax)	Measured by plasma concentrations	Up to 8 days
Secondary	Incidence of adverse events (AEs)	Measured by investigator assessment	Up to 8 days
Secondary	Results of electrocardiogram tests (ECGs)	Measured by investigator assessment	Up to 8 days
Secondary	Results of vital sign measurements	Measured by investigator assessment	Up to 8 days
Secondary	Results of clinical laboratory tests	Measured by investigator assessment	Up to 8 days

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form