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

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

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: CC-99677


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CC-99677<br> | Drug: CC-99677<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Incidence of physical examination abnormalities |  | Up to 15 days | 
| Incidence of clinical laboratory test abnormalities |  | Up to 15 days | 
| Cmax |  | Up to 15 days | 
| Tmax |  | Up to 15 days | 
| AUC(0-T) |  | Up to 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CC-99677, Healthy Male Participants, Pharmacokinetics, Absorption, Distribution, Metabolism, Excretion