HealthyPhase 1NCT02471690
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers
A Phase 1 study testing Oritavancin and Dextrose in people with Healthy, run by The Medicines Company at 1 site in United States.
Trial summary
The protocol describes a double-blind study to evaluate the Pharmacokinetics and safety of a new formulation of oritavancin by adjusting infusion time, concentration and reconstitution/administration solutions, of a single 1200 mg intravenous (IV) infusion of oritavancin Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oritavancin and Dextrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Apr 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent before initiation of any study related procedures.
- Healthy male or female between the ages of 18 and 65 years, inclusive.
- Body mass index (BMI) < 45 kg/m^2.
- Subject is in good health based on medical history and physical examination findings and has no clinically meaningful safety laboratory abnormalities (CBC, blood chemistry, and urinalysis) or 12 lead ECG results, as assessed by the PI.
- Vital signs (BP, pulse and temperature) measured at screening/baseline must be within the following ranges: SBP ≥90 to ≤150 mm Hg, DBP ≥45 to ≤90 mm Hg; Heart Rate ≥ 40 to ≤90 bpm (taken after resting in a supine position for at least 5 minutes).
- Willing to avoid all medications (other than the study drug and acetaminophen/paracetamol for minor aches/pains) during the study. This includes prescription and non-prescription medications, vitamins, herbal supplements, and nutraceuticals.
- Non-smoker and is willing to abstain from alcohol/illegal drug use for the duration of the study.
- If the female subject is surgically sterile, postmenopausal, or, if of childbearing potential, agrees to use at least 2 highly-effective 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.
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.
- Female subjects of childbearing potential that have a positive test result for human chorionic gonadotropin (hCG) at screening.
- Female subjects who are nursing.
- Positive urine test for alcohol and/or 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 units/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).
- History of hypersensitivity to drugs with a similar chemical structure (i.e. glycopeptide antibiotics) to oritavancin or any of its excipients.
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- Blood or plasma donation within the past 2 months.
- Subjects who participated in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days or 5 half-lives, whichever is longer, prior to screening 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 drugs, within 2 weeks or 5 half-lives, whichever is longer, or herbal nutritional supplements within 2 weeks of screening, with the exception of acetaminophen/paracetamol for minor aches/pains. 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.
- 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).
- Subjects that have any surgical or medical condition that could interfere with the administration of the study drug.
- Subjects that have known active hepatitis B or C, or human immunodeficiency virus (HIV) infection or has known immune deficiency disease at screening.
- Subjects that have any condition that would confound or interfere with the assessment of safety.
- Subjects that have poor IV access as determined by the investigator.
- Prior exposure to Oritavancin alone or in combination with another product.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Single Center Cohort Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Formulation of a Single 1200MG IV Dose of Oritavancin in Healthy Volunteers
The protocol describes a double-blind study to evaluate the Pharmacokinetics and safety of a new formulation of oritavancin by adjusting infusion time, concentration and reconstitution/administration solutions, of a single 1200 mg intravenous (IV) infusion of oritavancin
Read the detailed description
Oritavancin has been approved in the United States for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSIs) caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms. This is a Phase I, single center, double-blind, study evaluating the PK and safety of a new formulation of oritavancin by adjusting infusion time, concentration and reconstitution/administration solutions, of a single 1200 mg intravenous (IV) infusion of oritavancin in healthy adult subjects.
- Conditions
- Healthy
- Being tested
- Oritavancin, Dextrose
- Keywords
- Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OritavancinDrug
Also called Orbactiv
IV - Single dose 1200 mg Oritavancin
DextroseDrug
Also called Placebo
D5W 5% in Water
| Study group | Role | What they receive |
|---|---|---|
| Oritavancin | Active comparator | IV -Single Dose - 1200 mg Oritavancin Receives: Drug: Oritavancin |
| Placebo | Placebo comparator | 250 mL Dextrose 5% in Water Receives: Drug: Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & Tolerability: AEs/SAEs
A composite measure of the number and types of AE/SAEs encountered and relationship to time of dosing
Measured: From Consent up to 14 days following termination of the study drug infusion.
Safety & Tolerability: clinical safety laboratory results
A composite measure of multiple laboratory results assessing the clinical significance of any changes from baseline
Measured: From Consent up to 14 days following termination of the study drug infusion.
Safety & Tolerability: vital sign measurements
A composite of multiple vital sign measurements, assessing the clinical significance of any changes from baseline
Measured: From Consent up to 14 days following termination of the study drug infusion.
Safety & Tolerability: ECGs
A composite of multiple ECG measurements, assessing the clinical significance of any changes from baseline
Measured: From Consent up to 14 days following termination of the study drug infusion.
Safety & Tolerability: physical examination findings
A composite of multiple physical examination findings, assessing the clinical significance of any changes from baseline
Measured: From Consent up to 14 days following termination of the study drug infusion.
Secondary outcomes (5)
PK parameters: Cmax and area under the plasma concentration-time curve
maximum measured plasma concentration
Measured: From pre-dose until 168 hours from last dose
PK parameters: AUC
AUC from time zero to the time of the last measurable concentration
Measured: From pre-dose until 168 hours from last dose
PK parameters: t1/2
elimination half life
Measured: From pre-dose until 168 hours from last dose
PK parameters: volume of distribution [Vz] and CL]
Volume of distribution
Measured: From pre-dose to 168 hours from last dose
PK parameters: tmax
Time to Cmax
Measured: From pre-dose to 168 hours from last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionApr 2016
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Information, Study director, Melinta Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471690
- Sponsor's protocol ID
- MDCO-ORI-15-01
- Status last verified
- Dec 2023
- First submitted
- 9 Jun 2015
- 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
- A Randomized, Double-Blind, Single Center Cohort Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Formulation of a Single 1200MG IV Dose of Oritavancin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02471690
- Acronym / sponsor ID
- MDCO-ORI-15-01
- Conditions
- Healthy
- Keywords
- Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Jun 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 protocol describes a double-blind study to evaluate the Pharmacokinetics and safety of a new formulation of oritavancin by adjusting infusion time, concentration and reconstitution/administration solutions, of a single 1200 mg intravenous (IV) infusion of oritavancin
Detailed description
Oritavancin has been approved in the United States for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSIs) caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms. This is a Phase I, single center, double-blind, study evaluating the PK and safety of a new formulation of oritavancin by adjusting infusion time, concentration and reconstitution/administration solutions, of a single 1200 mg intravenous (IV) infusion of oritavancin in healthy adult subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oritavancin | Active comparator | Drug: OritavancinIV -Single Dose - 1200 mg Oritavancin |
| Placebo | Placebo comparator | Drug: Dextrose250 mL Dextrose 5% in Water |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to provide written informed consent before initiation of any study related procedures.
- Healthy male or female between the ages of 18 and 65 years, inclusive.
- Body mass index (BMI) < 45 kg/m^2.
- Subject is in good health based on medical history and physical examination findings and has no clinically meaningful safety laboratory abnormalities (CBC, blood chemistry, and urinalysis) or 12 lead ECG results, as assessed by the PI.
- Vital signs (BP, pulse and temperature) measured at screening/baseline must be within the following ranges: SBP ≥90 to ≤150 mm Hg, DBP ≥45 to ≤90 mm Hg; Heart Rate ≥ 40 to ≤90 bpm (taken after resting in a supine position for at least 5 minutes).
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.
- Female subjects of childbearing potential that have a positive test result for human chorionic gonadotropin (hCG) at screening.
- Female subjects who are nursing.
- Positive urine test for alcohol and/or 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 units/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).
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 |
|---|---|---|
| OritavancinAlso: OrbactivIV - Single dose 1200 mg Oritavancin | Drug | Oritavancin |
| DextroseAlso: PlaceboD5W 5% in Water | Drug | Placebo |
Primary outcome
Safety & Tolerability: AEs/SAEs
Time frame: From Consent up to 14 days following termination of the study drug infusion.
A composite measure of the number and types of AE/SAEs encountered and relationship to time of dosing
Safety & Tolerability: clinical safety laboratory results
Time frame: From Consent up to 14 days following termination of the study drug infusion.
A composite measure of multiple laboratory results assessing the clinical significance of any changes from baseline
Safety & Tolerability: vital sign measurements
Time frame: From Consent up to 14 days following termination of the study drug infusion.
A composite of multiple vital sign measurements, assessing the clinical significance of any changes from baseline
Safety & Tolerability: ECGs
Time frame: From Consent up to 14 days following termination of the study drug infusion.
A composite of multiple ECG measurements, assessing the clinical significance of any changes from baseline
Safety & Tolerability: physical examination findings
Time frame: From Consent up to 14 days following termination of the study drug infusion.
A composite of multiple physical examination findings, assessing the clinical significance of any changes from baseline
5 secondary outcomes
PK parameters: Cmax and area under the plasma concentration-time curve
Time frame: From pre-dose until 168 hours from last dose
PK parameters: AUC
Time frame: From pre-dose until 168 hours from last dose
PK parameters: t1/2
Time frame: From pre-dose until 168 hours from last dose
PK parameters: volume of distribution [Vz] and CL]
Time frame: From pre-dose to 168 hours from last dose
PK parameters: tmax
Time frame: From pre-dose to 168 hours from last dose
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.
Medical Information study director
Melinta Therapeutics, Inc.
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 Oritavancin and Dextrose in people with Healthy, run by The Medicines Company 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 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. 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?
Safety & Tolerability: AEs/SAEs (time frame: From Consent up to 14 days following termination of the study drug infusion.). The study lists 5 primary outcomes in all. 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.