NCT Number: NCT02234882
Study on Pharmacokinetics
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.
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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).
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
Treatment and study plan
BMS-663068
DrugPrimary outcomes
-
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
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
ViiV Healthcare
Industry
Collaborators
- GlaxoSmithKline
Registry information
Official study title
Effect of BMS-663068 on the Pharmacokinetics of Rosuvastatin
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Sep 9, 2014
- Registry last updated
- Apr 17, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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