HealthyPhase 1DDINCT01784536
Open Label Study Evaluating the Effects of a Single Oritavancin Infusion on Cytochrome P450 in Healthy Volunteers
A Phase 1 study testing Single-Dose IV Oritavancin Diphosphate in people with Healthy, run by Melinta Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Single-Dose IV Oritavancin Diphosphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Mar 2013
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Single-Dose IV Oritavancin Diphosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Dose IV Oritavancin DiphosphateDrug
Also called Oritavancin Diphosphate
Oritavancin will be administered as a single IV infusion. The infusion will last approximately 3 hours.
| Study group | Role | What they receive |
|---|---|---|
| Oritavancin | Experimental | Single-Dose IV Oritavancin Diphosphate Receives: Drug: Single-Dose IV Oritavancin Diphosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the phenotyping measures of each probe drug in the absence and presence of oritavancin
Measured: 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
Measured: Day 1 through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionMar 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT01784536
- Sponsor's protocol ID
- MDCO-ORI-12-03
- Acronym
- DDI
- Status last verified
- Dec 2023
- First submitted
- 4 Feb 2013
- 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
- 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
- ClinicalTrials.gov ID
- NCT01784536
- Acronym / sponsor ID
- DDI / MDCO-ORI-12-03
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 6 Feb 2013 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oritavancin | Experimental | Drug: Single-Dose IV Oritavancin DiphosphateSingle-Dose IV Oritavancin Diphosphate |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
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 DiphosphateAlso: Oritavancin DiphosphateOritavancin will be administered as a single IV infusion. The infusion will last approximately 3 hours. | Drug | Oritavancin |
Primary outcome
Change in the phenotyping measures of each probe drug in the absence and presence of oritavancin
Time frame: Day 1 through Day 5
1 secondary outcome
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
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 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 8 inclusion and 19 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?
Change in the phenotyping measures of each probe drug in the absence and presence of oritavancin (time frame: Day 1 through Day 5). 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.