Study on Pharmacokinetics
Information provided by (Responsible Party)
First received: September 5, 2014
Last updated: April 13, 2018
Last Verified: April 2018
History of Changes
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.
Drug : Rosuvastatin
Drug : BMS-663068
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
|Official Title:||Effect of BMS-663068 on the Pharmacokinetics of Rosuvastatin|
Further study details as provided by ViiV Healthcare:
Primary Outcome Measures
- Maximum observed plasma concentration (Cmax) of rosuvastatin [ Time Frame: Days 1 through 13 ]
- Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) of rosuvastatin [ Time Frame: Days 1 through 13 ]
- Trough blood samples of BMS-626529 concentration [ Time Frame: Days 7 through 13 ]
- Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests. [ Time Frame: 40 days ]
|Study Start Date:||September 5, 2014|
|Study Completion Date:||October 31, 2014|
|Primary Completion Date:||October 31, 2014 (Final data collection date for primary outcome measure)|
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
|Ages Eligible for Study:||18 Years to 50 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02234882
Sponsors and CollaboratorsViiV Healthcare
|Study Director:||ViiV Clinical Trials, MD||ViiV Healthcare|
|Responsible Party:||ViiV Healthcare|
|ClinicalTrials.gov Identifier:||NCT02234882 History of Changes|
|Other Study ID Numbers:||206276|
|Study First Received:||September 5, 2014|
|Last Updated:||April 13, 2018|
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.