Obese But Otherwise Healthy Participants Clinical Trial
Official title:
A Multiple Dose Pharmacokinetic/Pharmacodynamic and Safety and Tolerability Study of BMS-963272 in Obese But Otherwise Healthy Adults
| Verified date | May 2020 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will assess the safety and tolerability of multiple doses of BMS-963272 in obese but otherwise healthy participants.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | February 10, 2020 |
| Est. primary completion date | February 10, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | PRA Health Sciences - Lenexa | Lenexa | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma concentration of BMS-963272 (Cmax) | Day 1, Day 14 | ||
| Primary | Time of maximum observed concentration of BMS-963272 (Tmax) | Day 1, Day 14 | ||
| Primary | Area under the concentration-time curve in one dosing interval (AUC(TAU)) | Day 1, Day 14 | ||
| Primary | Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) | Day 14 | ||
| Primary | Apparent total clearance of the drug from plasma after oral administration (CLss/F) | Day 14 | ||
| Primary | Apparent volume of distribution at steady state (Vss/F) | Day 14 | ||
| Primary | Average concentration at steady state (Cavg,ss) | Day 14 | ||
| Primary | Half-life (T-HALF) | Day 14 | ||
| Primary | Accumulation index (AI) | Day 14 | ||
| Primary | Rate elimination constant (kel) of BMS-963272 | Day 14 | ||
| Primary | Area under the concentration-time curve (AUC) of triglycerides (TG) and fatty acids in response to the oral lipid tolerance test (oLTT) | Day 7, Day 15 | ||
| Primary | Incremental AUC (iAUC) of TG and fatty acids in response to the oLTT | Day 7, Day 15 | ||
| Secondary | Incidence of Adverse Events (AEs) | Up to 55 days | ||
| Secondary | Incidence of Serious Adverse Events (SAEs) | Up to 55 days | ||
| Secondary | Number of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations and clinical laboratory tests | Up to 55 days |