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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05284890
Collaborator
(none)
8
Enrollment
1
Arm
1.8
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Phase 1, Single-center, Open-label Study to Evaluate the Metabolism and Excretion of [14C]CC-99677 in Healthy Male Participants
Anticipated Study Start Date :
Mar 24, 2022
Anticipated Primary Completion Date :
May 18, 2022
Anticipated Study Completion Date :
May 19, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: CC-99677

Drug: CC-99677
Specified dose on specified days

Outcome Measures

Primary Outcome Measures

  1. Maximum plasma concentration of the drug (Cmax) for CC-99677 [Up to 15 days]

  2. Time of maximum observed plasma concentration (Tmax) for CC-99677 [Up to 15 days]

  3. 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]

  4. Total radioactivity recovered in urine (UR) [Up to 15 days]

  5. Percent of total radioactivity recovered in urine (%UR) [Up to 15 days]

  6. Total radioactivity recovered in feces (FR) [Up to 15 days]

  7. Percent of total radioactivity recovered in feces (%FR) [Up to 15 days]

  8. Total radioactivity recovered in bile (BR) [Up to 15 days]

  9. Total radioactivity recovered in urine, feces, and bile combined (Rtotal) [Up to 15 days]

  10. Percent of total radioactivity recovered in all excreta (%Total) [Up to 15 days]

  11. Plasma AUC (total radioactivity (TRA))/Blood AUC (TRA) [Up to 15 days]

Secondary Outcome Measures

  1. Incidence of adverse events (AEs) [Up to 50 days]

  2. Incidence of serious adverse events (SAEs) [Up to 50 days]

  3. Incidence of AEs leading to discontinuation [Up to 15 days]

  4. Incidence of vital sign abnormalities [Up to 15 days]

  5. Incidence of electrocardiogram (ECG) abnormalities [Up to 15 days]

  6. Incidence of physical examination abnormalities [Up to 15 days]

  7. Incidence of clinical laboratory test abnormalities [Up to 15 days]

  8. Cmax [Up to 15 days]

  9. Tmax [Up to 15 days]

  10. AUC(0-T) [Up to 15 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT05284890
Other Study ID Numbers:
  • IM046-001
First Posted:
Mar 17, 2022
Last Update Posted:
Mar 17, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bristol-Myers Squibb
CC-99677
Healthy Male Participants
Pharmacokinetics
Absorption
Distribution
Metabolism
Excretion

Study Results

No Results Posted as of Mar 17, 2022