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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: CC-99677

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704-2526
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CC-99677	Drug: CC-99677; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Actual): July 11, 2022
• Study Completion (Actual): July 11, 2022

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Distribution; Absorption; Metabolism; CC-99677; Excretion; Healthy Male Participants
• Other Study ID Numbers: IM046-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No