A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults

NCT04116632 | Completed Phase 1 FDA Drug

• 1 other identifier: MB006-017
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obese But Otherwise Healthy Participants

Outcome Measures

Primary Outcomes (12)

• Maximum observed plasma concentration of BMS-963272 (Cmax)

  Day 1, Day 14

• Time of maximum observed concentration of BMS-963272 (Tmax)

  Day 1, Day 14

• Area under the concentration-time curve in one dosing interval (AUC(TAU))

  Day 1, Day 14

• Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))

  Day 14

• Apparent total clearance of the drug from plasma after oral administration (CLss/F)

  Day 14

• Apparent volume of distribution at steady state (Vss/F)

  Day 14

• Average concentration at steady state (Cavg,ss)

  Day 14

• Half-life (T-HALF)

  Day 14

• Accumulation index (AI)

  Day 14

• Rate elimination constant (kel) of BMS-963272

  Day 14

• 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

• Incremental AUC (iAUC) of TG and fatty acids in response to the oLTT

  Day 7, Day 15

Secondary Outcomes (3)

• Incidence of Adverse Events (AEs)

  Up to 55 days

• Incidence of Serious Adverse Events (SAEs)

  Up to 55 days

• Number of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations and clinical laboratory tests

  Up to 55 days

Study Arms (3)

BMS-963272 or Placebo once daily (QD)

EXPERIMENTAL

Drug: BMS-963272; Drug: Placebo

BMS-963272 or Placebo every 12 hours (Q12H)

EXPERIMENTAL

Drug: BMS-963272; Drug: Placebo

BMS-963272 or Placebo every 8 hours (Q8H)

EXPERIMENTAL

Drug: BMS-963272; Drug: Placebo

Interventions

BMS-963272 DRUG

Single dose with varying frequency among groups

BMS-963272 or Placebo every 12 hours (Q12H); BMS-963272 or Placebo every 8 hours (Q8H); BMS-963272 or Placebo once daily (QD)

Placebo DRUG

Specified dose on specified days

BMS-963272 or Placebo every 12 hours (Q12H); BMS-963272 or Placebo every 8 hours (Q8H); BMS-963272 or Placebo once daily (QD)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

PRA Health Sciences - Lenexa

Lenexa, Kansas, 66219, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 4, 2019
• Study Start: September 30, 2019
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-05

Locations

US (1)