A Study to Assess the Drug-drug Interaction of BMS-963272 and Rosuvastatin

An Open-label, Single-sequence, Drug-drug Interaction Study to Assess the Effect of BMS-963272 Coadministration on the Systemic Exposure of Rosuvastatin in Healthy Participants

Phase 1 study that assesses the effect of BMS-963272 on exposure of rosuvastatin in healthy participants

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: BMS-963272; Drug: rosuvastatin

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • PRA Health Sciences - Salt Lake

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Inclusion Criteria:

• Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
• Women must not be of childbearing potential (WNOCBP)
• Women and men must agree to follow instructions for methods of contraception

Exclusion Criteria:

• Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study.
• Any major surgery within 4 weeks of study drug administration
• Any blood transfusion or donation of blood to a blood bank or in a clinical study within 4 weeks of study drug administration
• Previous treatment with BMS-963272
• Participants who smoke, as well as, those who have stopped smoking less than 6 months prior to day 1

Other protocol-defined inclusion/exclusion criteria could apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rosuvastatin + BMS-963272	Drug: BMS-963272; Specified dose on specified days; Drug: rosuvastatin; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum concentration (Cmax)	up to Day 10
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration AUC(0-T)	up to Day 10
Area under the plasma concentration-time curve extrapolated to infinity AUC (INF)	up to Day 10

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events (AEs)	Approximately 50 days
Number of significant changes in lab assessments of blood serum	Approximately 50 days
Number of significant changes in lab assessments of blood	Approximately 50 days
Number of significant changes in lab assessments of urine	Approximately 50 days
Blood pressure	Approximately 50 days
Body temperature	Approximately 50 days
Respiratory rate	Approximately 50 days
Number of Participants with abnormal physical examination findings	Approximately 50 days
Heart rate	Approximately 50 days
Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities	Approximately 50 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Actual): January 3, 2020
• Study Completion (Actual): January 3, 2020

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: MB006-018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No