HealthyPhase 1NCT02340988
Drug-Drug Interaction Potential of Orbactiv (Oritavancin) Co-Administered With Warfarin in Healthy Subjects
A Phase 1 study testing Single-Dose IV Oritavancin Diphosphate and Warfarin and Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post dose in people with Healthy, run by Melinta Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Single-Dose IV Oritavancin Diphosphate and Warfarin and Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is able to provide written informed consent before initiation of any study-related procedures.
- Subject is a healthy male or female adult between 18 and 55 years of age, inclusive.
- Subject has a body mass index (BMI) < 45 kg/m^2.
- Subject is in good health based on medical history and physical examination findings.
- 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.
- 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.
Who cannot join
- 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.
- Positive breath test for alcohol and/or positive urine test for drugs of abuse at Screening.
- 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).
- Blood or plasma donation within past 2 months.
- History of hypersensitivity to glycopeptide antibiotics (that have a similar chemical structure to oritavancin) or to any of the excipients of oritavancin.
- History of hypersensitivity to warfarin or other 4-hydroxycoumarins, or to any of the excipients of warfarin.
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- 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.
- 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.
- Females who are pregnant or nursing or who have a positive pregnancy test result at screening.
- 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)
- Known protein C or protein S deficiency.
- Inflammatory Bowel Disease or conditions which may decrease the absorption of warfarin.
- History of bleeding tendencies (e.g. history of menorrhagia, gastrointestinal bleeding).
- History of heparin-induced thrombocytopenia.
- Surgery within the last 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Assess the Drug-Drug Interaction Potential of a Single 1200 mg IV Dose of Orbactiv (Oritavancin) Co-Administered With Warfarin in Healthy Subjects.
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.
- Conditions
- Healthy
- Being tested
- Single-Dose IV Oritavancin Diphosphate and Warfarin, Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Dose IV Oritavancin Diphosphate and WarfarinDrug
Also called Oritavancin Diphosphate
Oritavancin will be administered as a single IV infusion simultaneously with Warfarin. The infusion will last approximately 3 hours.
Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post doseDrug
Also called Oritavancin Diphosphate
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.
| Study group | Role | What they receive |
|---|---|---|
| Oritavancin and Warfarin | Experimental | Oritavancin 1200 mg Single-Dose IV Oritavancin Diphosphate given simultaneously with 25mg dose of Warfarin Receives: Drug: Single-Dose IV Oritavancin Diphosphate and Warfarin |
| Warfarin 24 hours post dose | Experimental | 25mg dose of Warfarin given 24 hours post 1200 mg Single-Dose IV Oritavancin Diphosphate. Receives: Drug: Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Day 1 through Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melinta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Sanabria, MD, Principal investigator, Spaulding Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340988
- Sponsor's protocol ID
- MDCO-ORI-14-02
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2014
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Drug-Drug Interaction Potential of a Single 1200 mg IV Dose of Orbactiv (Oritavancin) Co-Administered With Warfarin in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT02340988
- Acronym / sponsor ID
- MDCO-ORI-14-02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oritavancin and Warfarin | Experimental | Drug: Single-Dose IV Oritavancin Diphosphate and WarfarinOritavancin 1200 mg Single-Dose IV Oritavancin Diphosphate given simultaneously with 25mg dose of Warfarin |
| Warfarin 24 hours post dose | Experimental | Drug: Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post dose25mg dose of Warfarin given 24 hours post 1200 mg Single-Dose IV Oritavancin Diphosphate. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject is able to provide written informed consent before initiation of any study-related procedures.
- Subject is a healthy male or female adult between 18 and 55 years of age, inclusive.
- Subject has a body mass index (BMI) < 45 kg/m^2.
- Subject is in good health based on medical history and physical examination findings.
- 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.
Key exclusion criteria (15 listed)
- 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.
- Positive breath test for alcohol and/or positive urine test for drugs of abuse at Screening.
- 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).
- Blood or plasma donation within past 2 months.
- History of hypersensitivity to glycopeptide antibiotics (that have a similar chemical structure to oritavancin) or to any of the excipients of oritavancin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-Dose IV Oritavancin Diphosphate and WarfarinAlso: Oritavancin DiphosphateOritavancin will be administered as a single IV infusion simultaneously with Warfarin. The infusion will last approximately 3 hours. | Drug | Oritavancin and Warfarin |
| Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post doseAlso: Oritavancin DiphosphateOritavancin 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. | Drug | Warfarin 24 hours post dose |
Primary outcome
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.
Time frame: Day 1-14
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.
1 secondary outcome
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
Time frame: Day 1 through Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Sanabria, MD principal investigator
Spaulding Clinical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single-Dose IV Oritavancin Diphosphate and Warfarin and Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post dose in people with Healthy, run by Melinta Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Day 1-14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.