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Open Label Study Evaluating the Effects of a Single Oritavancin Infusion on Cytochrome P450 in Healthy Volunteers (DDI)

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ClinicalTrials.gov Identifier: NCT01784536
Recruitment Status : Completed
First Posted : February 6, 2013
Last Update Posted : April 17, 2013
Sponsor:
Information provided by (Responsible Party):
The Medicines Company

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Single-Dose IV Oritavancin Diphosphate Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Evaluating the Effects of a Single Oritavancin Infusion on Cytochrome P450 (CYP) 1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A, N-Acetyltransferase-2, and Xanthine Oxidase Activities in Healthy Adults Using the Cooperstown 5 + 1 Cocktail
Study Start Date : January 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oritavancin
Single-Dose IV Oritavancin Diphosphate
Drug: Single-Dose IV Oritavancin Diphosphate
Oritavancin will be administered as a single IV infusion. The infusion will last approximately 3 hours.
Other Name: Oritavancin Diphosphate




Primary Outcome Measures :
  1. Change in the phenotyping measures of each probe drug in the absence and presence of oritavancin [ Time Frame: Day 1 through Day 5 ]

Secondary Outcome Measures :
  1. Safety of probe drug administration and prolonged infusion of oritavancin as assessed by AEs/SAEs, clinical safety laboratory results, vital sign measurements, 12 lead ECG results, and physical examination findings [ Time Frame: Day 1 through Day 28 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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/m2, 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 surface antigen, hepatitis C virus antibody, or has known hepatitis B or C infection at screening.
  • Positive serology result for human immunodeficiency virus (HIV) or has known immune deficiency disease at Screening.
  • Requires anticoagulant monitoring with an activated partial thromboplastin time.
  • Has an elevated international normalized ratio >1.3.
  • Surgical or medical condition that could interfere with the administration of the study drug.
  • Any condition that may affect drug absorption.
  • Has a known intolerance to benzodiazepines, the active and/or inactive ingredients in caffeine, warfarin, vitamin K, omeprazole, or dextromethorphan.
  • The use of any nicotine containing substance or nicotine replacement devices within 6 months before Screening.
  • Has received an immunization during the 2 week period before screening.
  • Has hemorrhagic tendencies or blood dyscrasias.
  • Has poor venous access as determined by the investigator.
  • Reports regular alcohol intake exceeding 1 drink/day within 1 month before screening.
  • A poor metabolizer (based on medical history, if known) of CYP2D6, CYP2C9, or CYP2C19.
  • Has participated in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days before enrollment.
  • Excluded for any of the previous criteria may not be rescreened for participation at any time.

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): NCT01784536


Locations
United States, Wisconsin
Spaulding Clinical
West Bend, Wisconsin, United States, 53095
Sponsors and Collaborators
The Medicines Company
Investigators
Principal Investigator: Carlos Sanabria, MD Spaulding Clinical

Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT01784536     History of Changes
Other Study ID Numbers: MDCO-ORI-12-03
First Posted: February 6, 2013    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Oritavancin
Anti-Bacterial Agents
Anti-Infective Agents