Clinical trial NCT06433505: A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants
Official title: A Phase 1, Open-label, Two-Part Study to Evaluate the Pharmacokinetics, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: BMS-986365
Pharmacokinetics
Absolute Bioavailability
Healthy Male Volunteers
CC-94676
ADME
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2024-05-29
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the pharmacokinetics (PK) and absolute bioavailability of BMS-986365 and to investigate the PK, metabolite profile, routes and extent of elimination, and mass balance of BMS-986365.


Eligibility criteria: Inclusion Criteria:

* Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations, as determined by the investigator
* Participants will require a left ventricular ejection fraction of \> 50% at screening.
* Body mass index of 18.0 to 32.0 kg/m2, inclusive, at screening. Body mass index = weight(kg)/(height \[m\])2.

Exclusion Criteria:

* Any current or recent significant acute or chronic illness.
* Participants with a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QTcF interval (\> 450 ms) at screening.
* Current or recent (within 3 months of intervention administration) gastrointestinal disease that could affect the absorption of study drug including cholecystectomy. Mild gastroesophageal reflux (even if managed with avoidance of food triggers) is exclusionary.
* History of allergy to BMS-986365 or related compounds.

Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Up to Day 60
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to Day 60
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
timeFrame: Up to Day 60
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC (INF))
timeFrame: Up to Day 60
measure: Apparent terminal plasma half-life (T-HALF)
timeFrame: Up to Day 60
measure: Total body clearance (CLT)
timeFrame: Up to Day 15
measure: Apparent total body clearance (CLT/F)
timeFrame: Up to Day 60
measure: Mean residence time (MRT)
timeFrame: Up to Day 15
measure: Apparent volume of distribution (Vz)
timeFrame: Up to Day 15
measure: Apparent volume of distribution (Vz/F)
timeFrame: Up to Day 60
measure: Absolute bioavailability (F)
timeFrame: Up to Day 15
Secondary outcomes:
measure: Number of participants with Adverse Events
timeFrame: Up to Day 60
measure: Number of participants with Serious Adverse Events
timeFrame: Up to Day 60
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to Day 60
measure: Number of participants with Vital sign abnormalities
timeFrame: Up to Day 60
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to Day 60
measure: Number of participants with physical examination abnormalities
timeFrame: Up to Day 60
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to Day 60
Other outcomes:
Locations:
city: Madison
country: United States
facility: Local Institution - 0001
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: