Clinical trial NCT04116632: A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults
Official title: A Multiple Dose Pharmacokinetic/Pharmacodynamic and Safety and Tolerability Study of BMS-963272 in Obese But Otherwise Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obese But Otherwise Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-10-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and tolerability of multiple doses of BMS-963272 in obese but otherwise healthy participants.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Participants must be in good general health, in the opinion of the investigator, with no clinically significant deviation from normal in medical history, physical examination findings, ECGs, or laboratory results.
* Participants must have a BMI of 30 kg/m2 to 40 kg/m2 inclusive
* Women (not of childbearing potential) and men aged 18 to 60 years, inclusive

Exclusion Criteria:

* Previous participation in the current study
* Inability or unwillingness to comply with protocol-defined restrictions or requirements regarding lifestyle, diet, concomitant medications, or other aspects of the study
* Inability to tolerate the oLTT meal or to comply with oLTT testing conditions
* Inability to tolerate oral medication
* Inability to tolerate venipuncture and/or inadequate venous access
* Women who are breastfeeding
* Medical Conditions
* History of lactose intolerance
* Any significant (in the opinion of the investigator) acute or chronic illness
* Type 1 or 2 diabetes
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
* Previous/Concomitant Therapy
* Previous exposure to BMS-963272

Other protocol-defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Maximum observed plasma concentration of BMS-963272 (Cmax)
timeFrame: Day 1, Day 14
measure: Time of maximum observed concentration of BMS-963272 (Tmax)
timeFrame: Day 1, Day 14
measure: Area under the concentration-time curve in one dosing interval (AUC(TAU))
timeFrame: Day 1, Day 14
measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
timeFrame: Day 14
measure: Apparent total clearance of the drug from plasma after oral administration (CLss/F)
timeFrame: Day 14
measure: Apparent volume of distribution at steady state (Vss/F)
timeFrame: Day 14
measure: Average concentration at steady state (Cavg,ss)
timeFrame: Day 14
measure: Half-life (T-HALF)
timeFrame: Day 14
measure: Accumulation index (AI)
timeFrame: Day 14
measure: Rate elimination constant (kel) of BMS-963272
timeFrame: Day 14
measure: Area under the concentration-time curve (AUC) of triglycerides (TG) and fatty acids in response to the oral lipid tolerance test (oLTT)
timeFrame: Day 7, Day 15
measure: Incremental AUC (iAUC) of TG and fatty acids in response to the oLTT
timeFrame: Day 7, Day 15
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 55 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 55 days
measure: Number of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations and clinical laboratory tests
timeFrame: Up to 55 days
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA Health Sciences - Lenexa
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: