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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04124003
• Other study ID #: MB006-018
• Status: Completed
• Phase: Phase 1
• Start date: October 8, 2019
• Est. completion date: January 3, 2020

Study information

• Verified date: March 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 3, 2020
• Est. primary completion date: January 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• rosuvastatin
Specified dose on specified days
• BMS-963272
Specified dose on specified days

Locations

Country	Name	City	State
United States	PRA Health Sciences - Salt Lake	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum concentration (Cmax)		up to Day 10
Primary	Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration AUC(0-T)		up to Day 10
Primary	Area under the plasma concentration-time curve extrapolated to infinity AUC (INF)		up to Day 10
Secondary	Incidence of Adverse Events (AEs)		Approximately 50 days
Secondary	Number of significant changes in lab assessments of blood serum		Approximately 50 days
Secondary	Number of significant changes in lab assessments of blood		Approximately 50 days
Secondary	Number of significant changes in lab assessments of urine		Approximately 50 days
Secondary	Blood pressure		Approximately 50 days
Secondary	Body temperature		Approximately 50 days
Secondary	Respiratory rate		Approximately 50 days
Secondary	Number of Participants with abnormal physical examination findings		Approximately 50 days
Secondary	Heart rate		Approximately 50 days
Secondary	Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities		Approximately 50 days

External Links

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