A Study to Evaluate the Drug Levels of [14C]CC-99677 in Healthy Male Participants
A Phase 1, Single-center, Open-label Study to Evaluate the Metabolism and Excretion of [14C]CC-99677 in Healthy Male Participants
1 other identifier
interventional
8
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started May 2022
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2022
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedStudy Start
First participant enrolled
May 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2022
CompletedDecember 1, 2022
November 1, 2022
2 months
March 9, 2022
November 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Maximum plasma concentration of the drug (Cmax) for CC-99677
Up to 15 days
Time of maximum observed plasma concentration (Tmax) for CC-99677
Up to 15 days
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
Total radioactivity recovered in urine (UR)
Up to 15 days
Percent of total radioactivity recovered in urine (%UR)
Up to 15 days
Total radioactivity recovered in feces (FR)
Up to 15 days
Percent of total radioactivity recovered in feces (%FR)
Up to 15 days
Total radioactivity recovered in bile (BR)
Up to 15 days
Total radioactivity recovered in urine, feces, and bile combined (Rtotal)
Up to 15 days
Percent of total radioactivity recovered in all excreta (%Total)
Up to 15 days
Plasma AUC (total radioactivity (TRA))/Blood AUC (TRA)
Up to 15 days
Secondary Outcomes (10)
Incidence of adverse events (AEs)
Up to 50 days
Incidence of serious adverse events (SAEs)
Up to 50 days
Incidence of AEs leading to discontinuation
Up to 15 days
Incidence of vital sign abnormalities
Up to 15 days
Incidence of electrocardiogram (ECG) abnormalities
Up to 15 days
- +5 more secondary outcomes
Study Arms (1)
CC-99677
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy male participants
- Body mass index of 18.0 to 33.0 kg/m\^2, inclusive
You may not qualify if:
- Any significant acute or chronic medical illness
- Any major surgery within 4 weeks of intervention administration
- History of any significant drug allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution - 0001
Madison, Wisconsin, 53704-2526, United States
Related Links
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2022
First Posted
March 17, 2022
Study Start
May 12, 2022
Primary Completion
July 11, 2022
Study Completion
July 11, 2022
Last Updated
December 1, 2022
Record last verified: 2022-11