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Study to Evaluate the Safety,Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471690
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
The Medicines Company

Brief 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

Condition or disease Intervention/treatment Phase
Healthy Drug: Oritavancin Drug: Dextrose Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Study Start Date : July 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Oritavancin

Arm Intervention/treatment
Active Comparator: Oritavancin
IV -Single Dose - 1200 mg Oritavancin
Drug: Oritavancin
IV - Single dose 1200 mg Oritavancin
Other Name: Orbactiv

Placebo Comparator: Placebo
250 mL Dextrose 5% in Water
Drug: Dextrose
D5W 5% in Water
Other Name: Placebo




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. PK parameters: Cmax and area under the plasma concentration-time curve [ Time Frame: From pre-dose until 168 hours from last dose ]
    maximum measured plasma concentration

  2. PK parameters: AUC [ Time Frame: From pre-dose until 168 hours from last dose ]
    AUC from time zero to the time of the last measurable concentration

  3. PK parameters: t1/2 [ Time Frame: From pre-dose until 168 hours from last dose ]
    elimination half life

  4. PK parameters: volume of distribution [Vz] and CL] [ Time Frame: From pre-dose to 168 hours from last dose ]
    Volume of distribution

  5. PK parameters: tmax [ Time Frame: From pre-dose to 168 hours from last dose ]
    Time to Cmax



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Able to provide written informed consent before initiation of any study related procedures.
  2. Healthy male or female between the ages of 18 and 65 years, inclusive.
  3. Body mass index (BMI) < 45 kg/m2.
  4. 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.
  5. 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).
  6. 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 nutriceuticals.
  7. Non-smoker and is willing to abstain from alcohol/illegal drug use for the duration of the study.
  8. 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.

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. Female subjects of childbearing potential that have a positive test result for human chorionic gonadotropin (hCG) at screening.
  3. Female subjects who are nursing.
  4. Positive urine test for alcohol and/or for drugs of abuse at screening.
  5. 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).
  6. History of hypersensitivity to drugs with a similar chemical structure (i.e. glycopeptide antibiotics) to oritavancin or any of its excipients.
  7. Blood or plasma donation within the past 2 months.
  8. 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.
  9. 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.
  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. Subjects that have any surgical or medical condition that could interfere with the administration of the study drug.
  12. Subjects that have known active hepatitis B or C, or human immunodeficiency virus (HIV) infection or has known immune deficiency disease at screening.
  13. Subjects that have any condition that would confound or interfere with the assessment of safety.
  14. Subjects that have poor IV access as determined by the investigator.
  15. Prior exposure to Oritavancin alone or in combination with another product.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471690


Locations
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United States, Wisconsin
Spaulding Clinical
West Bend, Wisconsin, United States, 53095
Sponsors and Collaborators
The Medicines Company
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Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT02471690    
Other Study ID Numbers: MDCO-ORI-15-01
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016
Keywords provided by The Medicines Company:
Volunteers
Additional relevant MeSH terms:
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Oritavancin
Anti-Bacterial Agents
Anti-Infective Agents