Pharmacokinetics and Metabolism Study in Healthy Male Participants

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03247283
• Other study ID #: CA017-052A
• Status: Completed
• Phase: Phase 1
• First received: August 7, 2017
• Last updated: October 31, 2017
• Start date: July 19, 2017
• Est. completion date: October 15, 2017

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 15, 2017
• Est. primary completion date: October 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• BMS-986205
Carbon 14 tagged BMS-986205

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit, Inc.	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 28 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 28 days
Primary	Half-Life (T-HALF)	Measured by plasma concentrations	up to 28 days
Primary	Total Body Clearance (CLT)	Measured by plasma concentrations	up to 28 days
Primary	Volume of Distribution during Terminal Elimination Phase (Vz/F)	Measured by plasma concentrations	up to 28 days
Primary	Time to Maximum Observed Concentration (Tmax)	Measured by plasma concentrations	up to 28 days
Secondary	Incidence of adverse events (AEs)	Measured by investigator assessment	up to 28 days
Secondary	Results of electrocardiogram tests (ECGs)	Measured by investigator assessment	up to 28 days
Secondary	Results of vital sign measurements	Measured by investigator assessment	up to 28 days
Secondary	Results of clinical laboratory tests	Measured by investigator assessment	up to 28 days

External Links

•   BMS Clinical Trial Education Resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form