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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: rosuvastatin; Drug: BMS-963272

• Registration Number: NCT04124003
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-08
• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-10-09
• Study First Posted: 2019-10-11
• Primary Completion: 2020-01-03
• Study Completion: 2020-01-03
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rosuvastatin + BMS-963272	BMS-963272	-
rosuvastatin + BMS-963272	rosuvastatin	-

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve extrapolated to infinity AUC (INF)	up to Day 10
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

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)	Approximately 50 days
Number of significant changes in lab assessments of urine	Approximately 50 days
Blood pressure	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
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

Trial Locations

Locations (1)

PRA Health Sciences - Salt Lake; 🇺🇸 Salt Lake City, Utah, United States