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CompletedNCT01784536DDIUpdated Dec 19, 2023

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

A Phase 1 interventional study of Single-Dose IV Oritavancin Diphosphate in Healthy, sponsored by Melinta Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-19.

Sponsored by Melinta Therapeutics, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Melinta Therapeutics, Inc. is the lead sponsor of 30 studies on the registry; none are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Oritavancin

    Single-Dose IV Oritavancin Diphosphate

    Drug: Single-Dose IV Oritavancin Diphosphate

Interventions

  • DrugSingle-Dose IV Oritavancin Diphosphate

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

    Also known as: Oritavancin Diphosphate

06

What researchers measure

Primary outcomes

  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 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

    Time frame: Day 1 through Day 28

07

Study locations

1 site
  • Spaulding Clinical
    West Bend, Wisconsin 53095, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01784536
Lead sponsor
Melinta Therapeutics, Inc.
Responsible party
Sponsor
First posted
Feb 6, 2013
Start date
Jan 2013
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Dec 19, 2023

Study contacts

Carlos Sanabria, MD
principal investigator · Spaulding Clinical

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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