A Study to Evaluate the Drug Levels of [14C]CC-99677 in Healthy Male Participants

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Single-center, Open-label Study to Evaluate the Metabolism and Excretion of [14C]CC-99677 in Healthy Male Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05284890
• Other study ID #: IM046-001
• Status: Completed
• Phase: Phase 1
• Start date: May 12, 2022
• Est. completion date: July 11, 2022

Study information

• Verified date: November 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to characterize the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of [14C] CC-99677.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 11, 2022
• Est. primary completion date: July 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male participants

• Body mass index of 18.0 to 33.0 kg/m^2, inclusive

Exclusion Criteria:

• Any significant acute or chronic medical illness

• Any major surgery within 4 weeks of intervention administration

• History of any significant drug allergy

Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• CC-99677
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	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	Maximum plasma concentration of the drug (Cmax) for CC-99677		Up to 15 days
Primary	Time of maximum observed plasma concentration (Tmax) for CC-99677		Up to 15 days
Primary	Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) for CC-99677		Up to 15 days
Primary	Total radioactivity recovered in urine (UR)		Up to 15 days
Primary	Percent of total radioactivity recovered in urine (%UR)		Up to 15 days
Primary	Total radioactivity recovered in feces (FR)		Up to 15 days
Primary	Percent of total radioactivity recovered in feces (%FR)		Up to 15 days
Primary	Total radioactivity recovered in bile (BR)		Up to 15 days
Primary	Total radioactivity recovered in urine, feces, and bile combined (Rtotal)		Up to 15 days
Primary	Percent of total radioactivity recovered in all excreta (%Total)		Up to 15 days
Primary	Plasma AUC (total radioactivity (TRA))/Blood AUC (TRA)		Up to 15 days
Secondary	Incidence of adverse events (AEs)		Up to 50 days
Secondary	Incidence of serious adverse events (SAEs)		Up to 50 days
Secondary	Incidence of AEs leading to discontinuation		Up to 15 days
Secondary	Incidence of vital sign abnormalities		Up to 15 days
Secondary	Incidence of electrocardiogram (ECG) abnormalities		Up to 15 days
Secondary	Incidence of physical examination abnormalities		Up to 15 days
Secondary	Incidence of clinical laboratory test abnormalities		Up to 15 days
Secondary	Cmax		Up to 15 days
Secondary	Tmax		Up to 15 days
Secondary	AUC(0-T)		Up to 15 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls