A Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male Participants

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Celgene

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: [14C]-BMS-986368

Study type

Interventional

Funder types

Industry

Identifiers

NCT06227975
IM045-1003

Details and patient eligibility

About

The purpose of this study is to investigate the pharmacokinetics (PK), metabolites, route of elimination, and mass balance of BMS-986368 in healthy male participants.

Enrollment

8 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations, as assessed by the investigator.
  • Body mass index of 18.0 to 35.0 kg/m2, inclusive. Body mass index = weight (kg)/(height[m])^2

Exclusion criteria

  • History of hypokalemia.
  • Any significant acute or chronic medical illness as determined by the investigator.
  • Participant has a history of syncope in the year prior to Day 1.

Other protocol-defined incusion/exclusion criteria apply.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

[14C]-BMS-986368
Experimental group
Treatment:
Drug: [14C]-BMS-986368

Trial contacts and locations

1

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Central trial contact

First line of the email MUST contain the NCT# and Site #.; BMS Study Connect Contact Center www.BMSStudyConnect.com

Data sourced from clinicaltrials.gov

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