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Study on Pharmacokinetics

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ClinicalTrials.gov Identifier: NCT02234882
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Rosuvastatin Drug: BMS-663068 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of BMS-663068 on the Pharmacokinetics of Rosuvastatin
Actual Study Start Date : September 5, 2014
Actual Primary Completion Date : October 31, 2014
Actual Study Completion Date : October 31, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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



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

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


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234882


Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
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Study Director: ViiV Clinical Trials, MD ViiV Healthcare
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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02234882    
Other Study ID Numbers: 206276
AI438-048 ( Other Identifier: Bristol-Myers Squibb )
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Fostemsavir
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors