Pharmacokinetics and Metabolism Study in Healthy Male Participants

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: BMS-986205

• Registration Number: NCT03247283
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-19
• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-11
• Status Verified: 2017-10
• Primary Completion: 2017-10-15
• Study Completion: 2017-10-15
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Oral Dose of BMS-986205	BMS-986205	-

Primary Outcome Measures

Name	Time	Method
Percent of Total Radioactivity Recovered in All Excreta (% total)	up to 28 days	Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts
Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])	up to 28 days	Measured by plasma concentrations
Half-Life (T-HALF)	up to 28 days	Measured by plasma concentrations
Total Body Clearance (CLT)	up to 28 days	Measured by plasma concentrations
Volume of Distribution during Terminal Elimination Phase (Vz/F)	up to 28 days	Measured by plasma concentrations
Time to Maximum Observed Concentration (Tmax)	up to 28 days	Measured by plasma concentrations

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Covance Clinical Research Unit, Inc.; 🇺🇸 Madison, Wisconsin, United States