A Study to Evaluate the Blood Levels, Safety, and Tolerability of BMS-986368 in Healthy Chinese Participants

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorCelgene

About this trial

The purpose of the study is to evaluate the drug levels, safety and tolerability of BMS-986368 in healthy Chinese participants

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants must be healthy male or non-pregnant and non-nursing female (as assigned at birth).

Participants must be of Chinese ethnicity (both biological parents should be ethnically Chinese).

Participants must have BMI of 18.0 kg/m2 to 28.0 kg/m2, inclusive and body weight of ≥ 50 kg.

Disqualifiers

Participants must not have personal or first-degree family history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, major depressive disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. Participants with a history of anxiety may be enrolled at the discretion of the investigator.

Participants must not have an active or prior history of stroke, chronic seizures, or major neurological disorders or has first-degree family relative who was diagnosed with these disorders below the age of 65 years.

Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BMS-986368

    Drug

    Specified dose on specified days

  • BMS-986368-matching Placebo

    Other intervention

    Specified dose of specified days

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: Cohort 1Experimental treatment 2 interventions
Group B: Cohort 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Maximum observed concentration (Cmax)

Time frame
Up to approximately Day 17
2

Time of maximum observed concentration (Tmax)

Time frame
Up to approximately Day 17
3

Area under the concentration-time curve (AUC)

Time frame
Up to approximately Day 17

Secondary outcomes

1

Number of participants with adverse events (AEs)

Time frame
Up to approximately Day 44
2

Number of participants with serious adverse events (SAEs)

Time frame
Up to approximately Day 44
3

Number of participants with clinically significant vital sign measurements

Time frame
Up to approximately Day 17
4

Number of participants with clinically significant 12-lead electrocardiogram (ECG) examinations

Time frame
Up to approximately Day 17

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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