Study on Pharmacokinetics

Effect of BMS-663068 on the Pharmacokinetics of Rosuvastatin

The purpose of this study is to assess the effect of the coadministration of multiple doses of BMS-663068 on the systemic exposure of rosuvastatin.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Rosuvastatin; Drug: BMS-663068

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed Informed Consent Form

   • Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's IRB or IEC before the initiation of any protocol-required procedures.

2. Target Population

   • Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, vital sign measurements, 12-lead ECG measurements, and clinical laboratory test results.

3. Age and Reproductive Status

   • Men and women of non-childbearing potential, ages 18 to 50 years, inclusive. Women must have documented proof that they are not of childbearing potential. Women must not be breastfeeding.
   • Males who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s).

Exclusion Criteria:

• Women who are of childbearing potential or breastfeeding
• Any significant acute or chronic medical illness
• History of rhabdomyolysis or biliary disorders, including Gilbert's disease or Dubin-Johnson disease
• Smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to the start of study drug administration)
• Alcohol intake exceeding 2 standard drinks per days; however, no alcohol is allowed 1 week prior to the start of study drug administration and for the duration of the study
• Any other sound medical, psychiatric, and/or social reason as determined by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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 and BMS-663068; Treatment A: Rosuvastatin, single dose (SD) Treatment B: BMS-663068 administered on specified days Treatment C: Combination BMS-663068 and Rosuvastatin administered on specified days	Drug: Rosuvastatin; Drug: BMS-663068

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax) of rosuvastatin	Days 1 through 13
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) of rosuvastatin	Days 1 through 13

Secondary Outcome Measures

Outcome Measure	Time Frame
Trough blood samples of BMS-626529 concentration	Days 7 through 13
Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.	40 days

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Collaborators: GlaxoSmithKline
• Investigators: Study Director: ViiV Clinical Trials, MD, ViiV Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2014
• Primary Completion (Actual): October 31, 2014
• Study Completion (Actual): October 31, 2014

Study Registration Dates

• First Submitted: September 5, 2014
• First Submitted That Met QC Criteria: September 5, 2014
• First Posted (Estimate): September 9, 2014

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 13, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Rosuvastatin Calcium; Fostemsavir
• Other Study ID Numbers: 206276; AI438-048 (Other Identifier: Bristol-Myers Squibb)