ClinicalTrials.gg
CompletedNCT02340988Updated Dec 19, 2023

Drug-Drug Interaction Potential of Orbactiv (Oritavancin) Co-Administered With Warfarin in Healthy Subjects

A Phase 1 interventional study of Single-Dose IV Oritavancin Diphosphate and Warfarin and Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post dose in Healthy, sponsored by Melinta Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-19.

Sponsored by Melinta Therapeutics, Inc. (part of CorMedix Therapeutics) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to assess the drug interaction potential and time course of the effect of oritavancin on warfarin pharmacokinetics in an open label, single arm manner.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Melinta Therapeutics, Inc. is the lead sponsor of 32 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.

First submitted before Melinta Therapeutics, Inc. became part of CorMedix Therapeutics.

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

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject is able to provide written informed consent before initiation of any study-related procedures.
  2. Subject is a healthy male or female adult between 18 and 55 years of age, inclusive.
  3. Subject has a body mass index (BMI) \< 45 kg/m\^2.
  4. Subject is in good health based on medical history and physical examination findings.
  5. Female subject is surgically sterile, postmenopausal, or, if of childbearing potential, agrees to use at least 2 acceptable methods of birth control (e.g. prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier methods, abstinence) or male partner sterilization alone for the duration of the study until 60 days after study drug administration.
  6. Subject agrees to abstain from caffeine and theobromine containing products and the consumption of Seville oranges, grapefruit (including grapefruit juice), broccoli, brussels sprouts, charcoal grilled meat, and energy drinks from 48 hours before study drug administration and throughout the clinical phase of the study.

Exclusion criteria

Exclusion Criteria:

  1. Has any condition, including findings in the medical history or in pre-study assessments that constitutes a risk or a contraindication for the participation in the study or completing the study.
  2. Positive breath test for alcohol and/or positive urine test for drugs of abuse at Screening.
  3. Has a history or presence of alcohol/drug abuse within 2 years. Alcohol abuse is defined as regularly consuming >3 units/day (21 units per week for men), >2 units/day (14 drinks/week) for women. 1 unit of alcohol is defined as a can of 4% beer (330 mL), approximately 190 mL of 6-7% beer (malt liquor), a glass of 40% spirits (30 mL), or a glass of wine (100 mL).
  4. Blood or plasma donation within past 2 months.
  5. History of hypersensitivity to glycopeptide antibiotics (that have a similar chemical structure to oritavancin) or to any of the excipients of oritavancin.
  6. History of hypersensitivity to warfarin or other 4-hydroxycoumarins, or to any of the excipients of warfarin.
  7. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 90 days prior to enrollment and/or unwilling to allow at least two months before participation in another drug trial following the current trial.
  8. Treatment with any prescription or OTC (over the counter) drugs or herbal nutritional supplements within 2 weeks of Screening, with the exception of acetaminophen/paracetamol for minor headache. Subjects will not be allowed to receive medications for the duration of the study (except the above-mentioned acetaminophen/paracetamol). Birth control or other hormone replacement is also permitted as long as it has been taken at a stable dose for at least three months before the Screening Visit and remains stable for the duration of the study.
  9. Females who are pregnant or nursing or who have a positive pregnancy test result at screening.
  10. Males who are unwilling to practice abstinence or use an acceptable method of birth control during the entire study period (i.e. condom with spermicide)
  11. Known protein C or protein S deficiency.
  12. Inflammatory Bowel Disease or conditions which may decrease the absorption of warfarin.
  13. History of bleeding tendencies (e.g. history of menorrhagia, gastrointestinal bleeding).
  14. History of heparin-induced thrombocytopenia.
  15. Surgery within the last 30 days.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Oritavancin and Warfarin

    Oritavancin 1200 mg Single-Dose IV Oritavancin Diphosphate given simultaneously with 25mg dose of Warfarin

    Drug: Single-Dose IV Oritavancin Diphosphate and Warfarin

  • Experimental
    Warfarin 24 hours post dose

    25mg dose of Warfarin given 24 hours post 1200 mg Single-Dose IV Oritavancin Diphosphate.

    Drug: Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post dose

Interventions

  • DrugSingle-Dose IV Oritavancin Diphosphate and Warfarin

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

    Also known as: Oritavancin Diphosphate

  • DrugSingle-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post dose

    Oritavancin will be administered as a single IV infusion and 24 hours post dose subjects will receive 25mg of Warfarin. The infusion will last approximately 3 hours.

    Also known as: Oritavancin Diphosphate

06

What researchers measure

Primary outcomes

  1. Primary Outcome Measure: Ratio of warfarin PK parameters - AUC and Cmax (area under the plasma concentration time curve and maximum plasma concentration) pre and post oritavancin dose and duration of effect.

    Ratio of warfarin PK parameters - AUC and Cmax (area under the plasma concentration time curve and maximum plasma concentration) pre and post oritavancin dose and duration of effect.

    Time frame: Day 1-14

Secondary outcomes

  1. Secondary Outcome Measures: Safety of the administration of warfarin and oritavancin will be assessed according to clinical laboratory parameters, and adverse events (AEs) and serious adverse events

    Safety of the administration of warfarin and oritavancin will be assessed according to clinical laboratory parameters, and adverse events (AEs) and serious adverse events (SAEs).

    Time frame: Day 1 through Day 21

07

Study locations

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

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2015, a primary completion of Sep 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2014
First posted
Jan 19, 2015
Start
Apr 2015
Primary completionActual
Sep 2015
CompletionActual
Sep 2015
Last update
Dec 19, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
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
NCT02340988
Responsible party
Sponsor
First posted
Jan 19, 2015
Start date
Apr 2015
Primary completion
Sep 2015
Completion
Sep 2015
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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