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NCT06411730

A Study to Evaluate the Safety, Tolerability, and Drug Levels of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity

A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity
Celgene·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Healthy Participants
Drug/Device/Intervention
BMS-986368
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Celgene
Location
Anaheim, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
May 14, 2024
End date
Oct 08, 2024
Enrollment
64 participants
Primary outcome

Number of participants with adverse events (AEs),Number of participants with serious adverse events (SAEs),Number of participants with vital sign (VS) abnormalities,Number of participants with physical examination abnormalities,Number of participants with electrocardiogram (ECG) abnormalities,Number of participants with clinical laboratory asssement abnormalities,Number of participants with treatment-emergent suicidal ideation and behavior through assessment of Columbia Suicide Severity Rating Scale (C-SSRS)

Summary

The purpose of this study is to evaluate the safety, tolerability, and drug levels of orally
 administered BMS-986368 in healthy participants, healthy elderly participants, and healthy
 participants of japanese ethnicity.

ICD-10 classifications
Seeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmfulHealthy person accompanying sick personRoutine general health check-up of sports teamsObesityPersons with potential health hazards related to communicable diseases
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06411730
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06411730 through Pure Global AI's free database. This Phase 1 trial is sponsored by Celgene and is currently Not yet recruiting. The study focuses on Healthy Participants. Target enrollment is 64 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.