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

NCT02471690 | Completed Phase 1

• 1 other identifier: MDCO-ORI-15-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

Volunteers

Outcome Measures

Primary Outcomes (5)

• Safety & Tolerability: AEs/SAEs

  A composite measure of the number and types of AE/SAEs encountered and relationship to time of dosing

  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

  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

  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

  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

  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

  From pre-dose until 168 hours from last dose

• PK parameters: AUC

  From pre-dose until 168 hours from last dose

• PK parameters: t1/2

  From pre-dose until 168 hours from last dose

• PK parameters: volume of distribution [Vz] and CL]

  From pre-dose to 168 hours from last dose

• PK parameters: tmax

  From pre-dose to 168 hours from last dose

Study Arms (2)

Oritavancin

ACTIVE COMPARATOR

IV -Single Dose - 1200 mg Oritavancin

Drug: Oritavancin

Placebo

PLACEBO COMPARATOR

250 mL Dextrose 5% in Water

Drug: Dextrose

Interventions

Oritavancin DRUG

IV - Single dose 1200 mg Oritavancin

Also known as: Orbactiv

Oritavancin

Dextrose DRUG

D5W 5% in Water

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The Medicines Company: lead

Study Sites (1)

Spaulding Clinical

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Interventions

oritavancin; Glucose

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Medical Information

  Melinta Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 15, 2015
• Study Start: July 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

US (1)