HealthyPhase 1NCT01762839
A Study to Assess the Cardiac Safety of Oritavancin in Healthy Participants
A Phase 1 study testing Single-Dose IV Oritavancin Diphosphate and Moxifloxacin in people with Healthy, run by Melinta Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of the study was to generate cardiac safety data using a supratherapeutic oritavancin dose of 1600 milligrams (mg). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Single-Dose IV Oritavancin Diphosphate and Moxifloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2012to 11 Feb 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to give written informed consent before initiation of any study related procedures and willing to comply with all required study procedures.
- Healthy, male and female between 18 and 60 years old, body mass index between 18 and 30 kilograms/meter squared.
- In good health based upon results of medical history, physical examination, no clinically significant 12-lead electrocardiogram (ECG) results, and laboratory test results.
- Serum magnesium and potassium levels within the normal range at Screening.
- Agreed 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
- History of immune-related hypersensitivity reaction to glycopeptides (such as vancomycin, televancin, daptomycin, or teicoplanin) or any of their excipients. Note: participants who had histamine-like infusion reactions to a glycopeptide were not excluded.
- A resting pulse rate < 50 beats per minute (bpm) or > 100 bpm.
- Systolic blood pressure < 90 millimeters of mercury (mmHg) or diastolic blood pressure < 50 mmHg.
- A QTc with the Fridericia correction > 450 microseconds (msec) (males) or > 470 msec (females).
- Respiratory difficulties, or a history of asthma or chronic obstructive pulmonary disease.
- Use of any prescription drug or over-the-counter medications or herbal preparations within 14 days or 5-times the elimination half-life (whichever was longer) prior to starting the study (except for acetaminophen; birth control pills; implantable or injectable birth control; and estrogen, testosterone, and/or progesterone replacement in menopausal women).
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- Unwilling to abstain from smoking for the duration of the study.
- Any clinically significant, underlying abnormalities in rhythm, conduction, or morphology of the resting ECG that may have interfered with the interpretation of QTc interval changes.
- Positive result for the urine or serum human chorionic gonadotropin test administered at Screening (females with childbearing potential).
- A past medical history of clinically significant ECG abnormalities or a family history (grandparents, parents, or siblings) of either a long or a short QT syndrome.
- Personal history of unexplained syncope.
- Women who were pregnant or nursing, or who were of childbearing potential and unwilling to use at least 2 acceptable methods of birth control (for example, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier method(s) or male partner sterilization). Women ≥ 2 years postmenopausal or surgically sterile were exempt from this exclusion.
- A history of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents.
- Positive virology screen for human immunodeficiency virus or hepatitis B or C virus, respectively.
- Participated in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment.
- Any condition, which in the opinion of the Investigator would put the participant at increased risk from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Design, Study With an Open-Label Positive-Control, to Assess the Cardiac Safety of Oritavancin in Healthy Volunteers
The purpose of the study was to generate cardiac safety data using a supratherapeutic oritavancin dose of 1600 milligrams (mg).
Read the detailed description
This study was a single-center, double-blind, randomized, placebo-controlled, parallel-design study with an open-label, positive-control moxifloxacin arm to evaluate the effect of supratherapeutic dose of oritavancin on the QT and QT corrected for pulse rate (QTc) intervals.
- Conditions
- Healthy
- Being tested
- Single-Dose IV Oritavancin Diphosphate, Placebo, Moxifloxacin
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
Intravenous oritavancin was administered via 2 dedicated, peripheral venous lines, 1 in each arm. The infusion lasted approximately 3 hours.
PlaceboDrug
Intravenous placebo was administered via 2 dedicated, peripheral venous lines, 1 in each arm. The infusion lasted approximately 3 hours.
MoxifloxacinDrug
Also called Avelox
Participants randomized to the open-label moxifloxacin treatment arm only received a 400-mg moxifloxacin tablet and did not receive a placebo infusion.
| Study group | Role | What they receive |
|---|---|---|
| Oritavancin | Experimental | Single-dose intravenous (IV) oritavancin diphosphate Receives: Drug: Single-Dose IV Oritavancin Diphosphate |
| Placebo | Placebo comparator | Single-dose IV placebo Receives: Drug: Placebo |
| Moxifloxacin | Active comparator | Moxifloxacin tablet Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-adjusted change from Baseline in QTcF
Placebo-adjusted change from baseline in QTcF (QTc with the Fridericia correction) between each treatment and placebo.
Measured: predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time
Secondary outcomes (4)
Placebo-adjusted change from baseline in QTcB, HR, RR, PR, and QRS interval analyses.
Placebo-adjusted change from baseline in QTcB, HR, RR, PR, and QRS interval analyses.
Measured: predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time
Placebo adjusted change from Baseline in the appearance or worsening of ST, T and U-wave morphology.
Placebo adjusted change from baseline in the appearance or worsening of ST, T and U-wave morphology.
Measured: predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time
Effects on the QTc interval related to plasma concentration levels of oritavancin
Compare the effects on the QTc interval to the plasma levels of oritavancin using concentration-effect modeling
Measured: predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time
Evaluate the number of volunteers with adverse events or abnormalities in lab/urine results and safety ECGs as measures of safety and tolerability
Compare safety and tolerability in healthy volunteers after a single IV dose of 1600 mg oritavancin
Measured: Day 0 through Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study start27 Dec 2012
- Primary completionJan 2013
- Study completion11 Feb 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 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
- NCT01762839
- Sponsor's protocol ID
- MDCO-ORI-12-02
- Status last verified
- Jan 2024
- First submitted
- 12 Dec 2012
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Parallel-Design, Study With an Open-Label Positive-Control, to Assess the Cardiac Safety of Oritavancin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01762839
- Acronym / sponsor ID
- MDCO-ORI-12-02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2012 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- 11 Feb 2013 (actual)
- First posted
- 8 Jan 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 the study was to generate cardiac safety data using a supratherapeutic oritavancin dose of 1600 milligrams (mg).
Detailed description
This study was a single-center, double-blind, randomized, placebo-controlled, parallel-design study with an open-label, positive-control moxifloxacin arm to evaluate the effect of supratherapeutic dose of oritavancin on the QT and QT corrected for pulse rate (QTc) intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oritavancin | Experimental | Drug: Single-Dose IV Oritavancin DiphosphateSingle-dose intravenous (IV) oritavancin diphosphate |
| Placebo | Placebo comparator | Drug: PlaceboSingle-dose IV placebo |
| Moxifloxacin | Active comparator | Drug: MoxifloxacinMoxifloxacin tablet |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able to give written informed consent before initiation of any study related procedures and willing to comply with all required study procedures.
- Healthy, male and female between 18 and 60 years old, body mass index between 18 and 30 kilograms/meter squared.
- In good health based upon results of medical history, physical examination, no clinically significant 12-lead electrocardiogram (ECG) results, and laboratory test results.
- Serum magnesium and potassium levels within the normal range at Screening.
- Agreed 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.
Key exclusion criteria (16 listed)
- History of immune-related hypersensitivity reaction to glycopeptides (such as vancomycin, televancin, daptomycin, or teicoplanin) or any of their excipients. Note: participants who had histamine-like infusion reactions to a glycopeptide were not excluded.
- A resting pulse rate < 50 beats per minute (bpm) or > 100 bpm.
- Systolic blood pressure < 90 millimeters of mercury (mmHg) or diastolic blood pressure < 50 mmHg.
- A QTc with the Fridericia correction > 450 microseconds (msec) (males) or > 470 msec (females).
- Respiratory difficulties, or a history of asthma or chronic obstructive pulmonary disease.
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 DiphosphateIntravenous oritavancin was administered via 2 dedicated, peripheral venous lines, 1 in each arm. The infusion lasted approximately 3 hours. | Drug | Oritavancin |
| PlaceboIntravenous placebo was administered via 2 dedicated, peripheral venous lines, 1 in each arm. The infusion lasted approximately 3 hours. | Drug | Placebo |
| MoxifloxacinAlso: AveloxParticipants randomized to the open-label moxifloxacin treatment arm only received a 400-mg moxifloxacin tablet and did not receive a placebo infusion. | Drug | Moxifloxacin |
Primary outcome
Placebo-adjusted change from Baseline in QTcF
Time frame: predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time
Placebo-adjusted change from baseline in QTcF (QTc with the Fridericia correction) between each treatment and placebo.
4 secondary outcomes
Placebo-adjusted change from baseline in QTcB, HR, RR, PR, and QRS interval analyses.
Time frame: predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time
Placebo adjusted change from Baseline in the appearance or worsening of ST, T and U-wave morphology.
Time frame: predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time
Effects on the QTc interval related to plasma concentration levels of oritavancin
Time frame: predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time
Evaluate the number of volunteers with adverse events or abnormalities in lab/urine results and safety ECGs as measures of safety and tolerability
Time frame: Day 0 through Day 7
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 1 Feb 2024.
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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 Moxifloxacin 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 5 inclusion and 16 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 1 Feb 2024. 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. Some participants in this study may receive a placebo. 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?
Placebo-adjusted change from Baseline in QTcF (time frame: predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time). 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 1 Feb 2024.