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

NCT ID: NCT02471690

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-04-30

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

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

Keywords

Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Oritavancin

IV -Single Dose - 1200 mg Oritavancin

Group Type: ACTIVE_COMPARATOR

Oritavancin

Intervention Type: DRUG

IV - Single dose 1200 mg Oritavancin

Placebo

250 mL Dextrose 5% in Water

Group Type: PLACEBO_COMPARATOR

Dextrose

Intervention Type: DRUG

D5W 5% in Water

Interventions

Oritavancin

IV - Single dose 1200 mg Oritavancin

Intervention Type: DRUG

Dextrose

D5W 5% in Water

Intervention Type: DRUG

Other Intervention Names

Orbactiv; Placebo

Eligibility 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/m^2.

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 nutraceuticals.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Medicines Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Information

Role: STUDY_DIRECTOR

Melinta Therapeutics, Inc.

Locations

Spaulding Clinical

West Bend, Wisconsin, United States

Countries

United States

Other Identifiers

MDCO-ORI-15-01

Identifier Type: -

Identifier Source: org_study_id