Pharmacokinetics and Metabolism Study in Healthy Male Participants

Pharmacokinetics and Metabolism of [14C] BMS-986205 in Healthy Male Participants

Phase 1 Phamacokinetic and metabolism study of BMS-986205 in healthy males

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: BMS-986205

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Body weight 75-95kg, BMI 18.0-32.0 kg/m^2
• Refrain from sperm donation 110 days after dosing

Exclusion Criteria:

• Current or recent gastrointestinal disease
• Any GI surgery that could impact drug absorption
• Active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• 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: Single Oral Dose of BMS-986205	Drug: BMS-986205; Carbon 14 tagged BMS-986205

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 28 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 28 days
Half-Life (T-HALF)	Measured by plasma concentrations	up to 28 days
Total Body Clearance (CLT)	Measured by plasma concentrations	up to 28 days
Volume of Distribution during Terminal Elimination Phase (Vz/F)	Measured by plasma concentrations	up to 28 days
Time to Maximum Observed Concentration (Tmax)	Measured by plasma concentrations	up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs)	Measured by investigator assessment	up to 28 days
Results of electrocardiogram tests (ECGs)	Measured by investigator assessment	up to 28 days
Results of vital sign measurements	Measured by investigator assessment	up to 28 days
Results of clinical laboratory tests	Measured by investigator assessment	up to 28 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Principal Investigator: Bristol- Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Education Resource
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2017
• Primary Completion (Actual): October 15, 2017
• Study Completion (Actual): October 15, 2017

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Linrodostat
• Other Study ID Numbers: CA017-052A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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