A Study to Assess the Cardiac Safety of Oritavancin in Healthy Participants

NCT ID: NCT01762839

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-27
• Study Completion Date: 2013-02-11

Brief Summary

The purpose of the study was to generate cardiac safety data using a supratherapeutic oritavancin dose of 1600 milligrams (mg).

Detailed Description

This study was a single-center, double-blind, randomized, placebo-controlled, parallel-design study with an open-label, positive-control moxifloxacin arm to evaluate the effect of supratherapeutic dose of oritavancin on the QT and QT corrected for pulse rate (QTc) intervals.

Conditions

Healthy

Study Design

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

Study Groups

Oritavancin

Single-dose intravenous (IV) oritavancin diphosphate

Group Type: EXPERIMENTAL

Single-Dose IV Oritavancin Diphosphate

Intervention Type: DRUG

Intravenous oritavancin was administered via 2 dedicated, peripheral venous lines, 1 in each arm. The infusion lasted approximately 3 hours.

Placebo

Single-dose IV placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intravenous placebo was administered via 2 dedicated, peripheral venous lines, 1 in each arm. The infusion lasted approximately 3 hours.

Moxifloxacin

Moxifloxacin tablet

Group Type: ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type: DRUG

Participants randomized to the open-label moxifloxacin treatment arm only received a 400-mg moxifloxacin tablet and did not receive a placebo infusion.

Interventions

Single-Dose IV Oritavancin Diphosphate

Intravenous oritavancin was administered via 2 dedicated, peripheral venous lines, 1 in each arm. The infusion lasted approximately 3 hours.

Intervention Type: DRUG

Placebo

Intravenous placebo was administered via 2 dedicated, peripheral venous lines, 1 in each arm. The infusion lasted approximately 3 hours.

Intervention Type: DRUG

Moxifloxacin

Participants randomized to the open-label moxifloxacin treatment arm only received a 400-mg moxifloxacin tablet and did not receive a placebo infusion.

Intervention Type: DRUG

Other Intervention Names

Oritavancin Diphosphate; Avelox

Eligibility Criteria

Inclusion Criteria

1. Able to give written informed consent before initiation of any study related procedures and willing to comply with all required study procedures.

2. Healthy, male and female between 18 and 60 years old, body mass index between 18 and 30 kilograms/meter squared.

3. In good health based upon results of medical history, physical examination, no clinically significant 12-lead electrocardiogram (ECG) results, and laboratory test results.

4. Serum magnesium and potassium levels within the normal range at Screening.

5. Agreed to abstain from alcohol, caffeine-, and xanthine-containing products, all kind of energy drinks and the consumption of grapefruit juice and orange juice from 48 hours before study drug administration until completion of the follow-up visit.

Exclusion Criteria

1. History of immune-related hypersensitivity reaction to glycopeptides (such as vancomycin, televancin, daptomycin, or teicoplanin) or any of their excipients. Note: participants who had histamine-like infusion reactions to a glycopeptide were not excluded.

2. A resting pulse rate < 50 beats per minute (bpm) or > 100 bpm.

3. Systolic blood pressure < 90 millimeters of mercury (mmHg) or diastolic blood pressure < 50 mmHg.

4. A QTc with the Fridericia correction > 450 microseconds (msec) (males) or > 470 msec (females).

5. Respiratory difficulties, or a history of asthma or chronic obstructive pulmonary disease.

6. Use of any prescription drug or over-the-counter medications or herbal preparations within 14 days or 5-times the elimination half-life (whichever was longer) prior to starting the study (except for acetaminophen; birth control pills; implantable or injectable birth control; and estrogen, testosterone, and/or progesterone replacement in menopausal women).

7. Unwilling to abstain from smoking for the duration of the study.

8. Any clinically significant, underlying abnormalities in rhythm, conduction, or morphology of the resting ECG that may have interfered with the interpretation of QTc interval changes.

9. Positive result for the urine or serum human chorionic gonadotropin test administered at Screening (females with childbearing potential).

10. A past medical history of clinically significant ECG abnormalities or a family history (grandparents, parents, or siblings) of either a long or a short QT syndrome.

11. Personal history of unexplained syncope.

12. Women who were pregnant or nursing, or who were of childbearing potential and unwilling to use at least 2 acceptable methods of birth control (for example, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier method(s) or male partner sterilization). Women ≥ 2 years postmenopausal or surgically sterile were exempt from this exclusion.

13. A history of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents.

14. Positive virology screen for human immunodeficiency virus or hepatitis B or C virus, respectively.

15. Participated in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment.

16. Any condition, which in the opinion of the Investigator would put the participant at increased risk from participating in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Melinta Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Sanabria, MD

Role: PRINCIPAL_INVESTIGATOR

Spaulding Clinical

Locations

Spaulding Clinical

West Bend, Wisconsin, United States

Countries

United States

Other Identifiers

MDCO-ORI-12-02

Identifier Type: -

Identifier Source: org_study_id