Clinical trial NCT05284890: A Study to Evaluate the Drug Levels of [14C]CC-99677 in Healthy Male Participants
Official title: A Phase 1, Single-center, Open-label Study to Evaluate the Metabolism and Excretion of [14C]CC-99677 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: CC-99677
Healthy Male Participants
Pharmacokinetics
Absorption
Distribution
Metabolism
Excretion
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-03-17
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum plasma concentration of the drug (Cmax) for CC-99677
timeFrame: Up to 15 days
measure: Time of maximum observed plasma concentration (Tmax) for CC-99677
timeFrame: Up to 15 days
measure: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) for CC-99677
timeFrame: Up to 15 days
measure: Total radioactivity recovered in urine (UR)
timeFrame: Up to 15 days
measure: Percent of total radioactivity recovered in urine (%UR)
timeFrame: Up to 15 days
measure: Total radioactivity recovered in feces (FR)
timeFrame: Up to 15 days
measure: Percent of total radioactivity recovered in feces (%FR)
timeFrame: Up to 15 days
measure: Total radioactivity recovered in bile (BR)
timeFrame: Up to 15 days
measure: Total radioactivity recovered in urine, feces, and bile combined (Rtotal)
timeFrame: Up to 15 days
measure: Percent of total radioactivity recovered in all excreta (%Total)
timeFrame: Up to 15 days
measure: Plasma AUC (total radioactivity (TRA))/Blood AUC (TRA)
timeFrame: Up to 15 days
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 50 days
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 50 days
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to 15 days
measure: Incidence of vital sign abnormalities
timeFrame: Up to 15 days
measure: Incidence of electrocardiogram (ECG) abnormalities
timeFrame: Up to 15 days
measure: Incidence of physical examination abnormalities
timeFrame: Up to 15 days
measure: Incidence of clinical laboratory test abnormalities
timeFrame: Up to 15 days
measure: Cmax
timeFrame: Up to 15 days
measure: Tmax
timeFrame: Up to 15 days
measure: AUC(0-T)
timeFrame: Up to 15 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Local Institution - 0001
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: