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

NCT01784536 | Completed Phase 1

• 1 other identifier: MDCO-ORI-12-03
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change in the phenotyping measures of each probe drug in the absence and presence of oritavancin

  Day 1 through Day 5

Secondary Outcomes (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

  Day 1 through Day 28

Study Arms (1)

Oritavancin

EXPERIMENTAL

Single-Dose IV Oritavancin Diphosphate

Drug: Single-Dose IV Oritavancin Diphosphate

Interventions

Single-Dose IV Oritavancin Diphosphate DRUG

Oritavancin will be administered as a single IV infusion. The infusion will last approximately 3 hours.

Also known as: Oritavancin Diphosphate

Oritavancin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Melinta Therapeutics, Inc.: lead

Study Sites (1)

Spaulding Clinical

West Bend, Wisconsin, 53095, United States

Location

Study Officials

• Carlos Sanabria, MD

  Spaulding Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 6, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

US (1)