Drug Interaction Statin

Acute Coronary Syndromes Clinical Trial

Official title:

A Phase 1 Open-label, Single-sequence Study to Evaluate the Effect of Coadministration of BMS-919373 on the Single-dose Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089061
• Other study ID #: CV205-029
• Status: Completed
• Phase: Phase 1
• First received: March 14, 2014
• Last updated: August 13, 2014
• Start date: March 2014
• Est. completion date: May 2014

Study information

• Verified date: August 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This purpose of this study is to assess the effects of BMS-919373 on the single dose Pharmacokinetics (PK) of Rosuvastatin and Atorvastatin in healthy subjects.

Description:

Primary Purpose: Other - To assess the effects of BMS-919373 on the single dose PK of Rosuvastatin and Atorvastatin in healthy subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Signed Written Informed Consent form

• Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examination, physical measurements, vital signs, 12-lead ECG, 24-hour telemetry, and clinical laboratory tests

• Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive

• Men and women, ages 18 to 55 yrs, inclusive

Exclusion Criteria:

• Current or history of cardiovascular diseases, including arrhythmias, coronary heart disease, and congestive heart failure

• Current or history of symptomatic hypotension

• Current or history of liver diseases, including cirrhosis and liver failure

• Current or history of kidney diseases, including nephrotic syndrome, renal failure, nephrolithiasis, and urolithiasis

• Current or history of neurological diseases, including presyncope, syncope, convulsive disorders such as epilepsy, cerebral thrombosis and cerebral embolism, transient ischemic attack, and stroke; or mental disorders Exceptions for presyncope/syncope related to vasovagal responses are allowable at the discretion of the investigator

• History of significant head injury in the last 2 years

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes

Intervention

Drug:
• BMS-919373

• Rosuvastatin

• Atorvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of Rosuvastatin and Atorvastatin		28 timepoints up to day 10	No
Primary	Area under the plasma concentration-time curve from time zero to 72 hours (AUC(0-72)) of Rosuvastatin and Atorvastatin		26 timepoints up to day 8	No
Primary	Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Rosuvastatin and Atorvastatin		28 timepoints up to day 10	No
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin and Atorvastatin		28 timepoints up to day 10	No
Secondary	Time of maximum observed plasma concentration (Tmax) of Rosuvastatin and Atorvastatin		28 timepoints up to day 10	No
Secondary	Terminal plasma half life (T-HALF) of Rosuvastatin and Atorvastatin		28 timepoints up to day 10	No
Secondary	Apparent total body clearance (CLT/F) of Rosuvastatin and Atorvastatin		28 timepoints up to day 10	No
Secondary	Safety based on results of physical examinations, vital sign measurements, ECGs, 24-hour telemetry, clinical laboratory tests, and physical measurements and will also include the incidence of AEs, SAEs and AEs leading to discontinuation	Adverse Event (AE); Serious Adverse Event (SAE)	Up to day 10	Yes