Open Label Study Evaluating the Effects of a Single Oritavancin Infusion on Cytochrome P450 in He… (NCT01784536) | Clinical Trial Compass
CompletedPhase 1
Open Label Study Evaluating the Effects of a Single Oritavancin Infusion on Cytochrome P450 in Healthy Volunteers
United States16 participantsStarted 2013-01
Plain-language summary
The purpose of this study is to examine the effects of oritavancin on the in vivo activities of CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A, NAT 2, and XO using a Cooperstown 5 + 1 cocktail in an open label, single arm manner.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* Provides written informed consent before study initiation.
* Healthy male or female adult between 18 and 45 years of age, inclusive.
* Body mass index (BMI) between 18 and 32 kg/m\^2, inclusive.
* Nonsmoker for a 6-month period before Screening.
* In good health based upon results of medical history, physical examination, no clinically significant 12-lead ECG results, and laboratory test results.
* Agrees to avoid all medications (other than the study drugs) that may inhibit or induce hepatic microsomal enzymes during the study period, including prescription and nonprescription medications, vitamins, herbal supplements (including energy drinks), and nutraceuticals.
* Female subject is surgically sterile, postmenopausal, or, if of childbearing potential, agrees to use an acceptable nonhormonal method of contraception during all study phases.
* Agree to abstain from alcohol, caffeine-, and xanthine-containing products, all kind of energy drinks and the consumption of grapefruit juice and orange juice from 48 hours before study drug administration until completion of the follow-up visit.
Exclusion Criteria:
* Has acute or chronic respiratory disease.
* The use of nonprescription drugs during the 30-day period before screening.
* The use of any prescription drugs during the 3-month period before.
* Childbearing potential, a positive test result for urine or serum, human chorionic gonadotropin (hCG) at Screening.
* Positive serology result for hepatitis B …
What they're measuring
1
Change in the phenotyping measures of each probe drug in the absence and presence of oritavancin