Pure Global

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 - Trial NCT06411730

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.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT06411730
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06411730
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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

Study Focus

Healthy Participants

BMS-986368

Interventional

drug

Sponsor & Location

Celgene

Anaheim, United States of America

Timeline & Enrollment

Phase 1

May 14, 2024

Oct 08, 2024

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 harmful
Healthy person accompanying sick person
Routine general health check-up of sports teams
Obesity
Persons with potential health hazards related to communicable diseases

Data Source

ClinicalTrials.gov

NCT06411730

Non-Device Trial