Study on Pharmacokinetics

NCT02234882 | Completed Phase 1

• 2 other identifiers: 206276AI438-048
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (1)

Rosuvastatin and BMS-663068

EXPERIMENTAL

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

Interventions

Rosuvastatin DRUG

Rosuvastatin and BMS-663068

BMS-663068 DRUG

Rosuvastatin and BMS-663068

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• ViiV Healthcare: lead
• GlaxoSmithKline: collaborator

MeSH Terms

Conditions

HIV Infections

Interventions

Rosuvastatin Calcium; fostemsavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• ViiV Clinical Trials, MD

  ViiV Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 9, 2014
• Study Start: September 5, 2014
• Primary Completion: October 31, 2014
• Study Completion: October 31, 2014
• Last Updated: April 17, 2018

Record last verified: 2018-04