Multiple Oritavancin Doses on Safety, Tolerability, and Pharmacokinetics in Healthy Subjects

NCT02470702 | Completed Phase 1 DMC

• 1 other identifier: MDCO-ORI-15-02
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol describes a double-blind study to evaluate the safety and pharmacokinetics of multiple IV doses of 1200 mg ORBACTIV (oritavancin) in healthy subjects.

Conditions

Healthy

Keywords

Volunteers

Outcome Measures

Primary Outcomes (5)

• Safety & Tolerability: AEs/SAEs

  a composite measure of the number and types of AEs/SAEs encountered and relationship to time of dosing

  From consent until day 110 safety follow up call

• Safety & Tolerability: clinical safety laboratory results

  A composite measure of multiple laboratory results assessing the clinical significance of any changes from baseline

  From consent until day 110 safety follow up call

• Safety & Tolerability: vital sign measurements

  A composite of multiple vital sign measurements, assessing the clinical significance of any changes from baseline

  From consent until day 110 safety follow up call

• Safety & Tolerability: ECGs

  A composite of multiple ECG measurements, assessing the clinical significance of any changes from baseline

  From consent until day 110 safety follow up call

• Safety & Tolerability: physical examination findings

  A composite of multiple physical examination findings, assessing the clinical significance of any changes from baseline

  From consent until day 110 safety follow up call

Secondary Outcomes (9)

• Pharmacokinetics: AUC0-last

  From pre-dose until 720 hours past last dose

• Pharmacokinetics: AUC0-72

  From pre-dose until 72 hours past last dose

• Pharmacokinetics: AUC0-∞

  From pre-dose until 720 hours past last dose

• Pharmacokinetics: Cmax

  From pre-dose until 720 hours past last dose

• Pharmacokinetics: Cmin

  From pre-dose until 720 hours past last dose

Study Arms (2)

Oritavancin

EXPERIMENTAL

Subjects randomized to oritavancin will receive four doses (Cohort 1) or eight doses (Cohort 2) of 1200 mg oritavancin, infused intravenously over 3 hours

Drug: Oritavancin

Placebo

PLACEBO COMPARATOR

Subjects randomized to placebo will receive four doses (Cohort 1) or eight doses (Cohort 2) of 1000 mL D5W, infused intravenously over 3 hours

Drug: Placebo (D5W)

Interventions

Oritavancin DRUG

Oritavancin

Placebo (D5W) DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is able to provide written informed consent before initiation of any study-related procedures.
• Healthy male or female between the ages of 18 and 55 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.
• Subject is a 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. Subjects excluded for any of the previous criteria may only be rescreened for participation after discussion with sponsor and principal investigator.
• Prior exposure to Oritavancin alone or in combination with another product.

Sponsors & Collaborators

• Melinta Therapeutics, Inc.: lead

Study Sites (1)

Unknown Facility

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Interventions

oritavancin

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: May 8, 2015
• First Posted: June 12, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

US (1)