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

NCT01762839 | Completed Phase 1

• 1 other identifier: MDCO-ORI-12-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Placebo-adjusted change from Baseline in QTcF

  Placebo-adjusted change from baseline in QTcF (QTc with the Fridericia correction) between each treatment and placebo.

  predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time

Secondary Outcomes (4)

• Placebo-adjusted change from baseline in QTcB, HR, RR, PR, and QRS interval analyses.

  predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time

• Placebo adjusted change from Baseline in the appearance or worsening of ST, T and U-wave morphology.

  predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time

• Effects on the QTc interval related to plasma concentration levels of oritavancin

  predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time

• Evaluate the number of volunteers with adverse events or abnormalities in lab/urine results and safety ECGs as measures of safety and tolerability

  Day 0 through Day 7

Study Arms (3)

Oritavancin

EXPERIMENTAL

Single-dose intravenous (IV) oritavancin diphosphate

Drug: Single-Dose IV Oritavancin Diphosphate

Placebo

PLACEBO COMPARATOR

Single-dose IV placebo

Drug: Placebo

Moxifloxacin

ACTIVE COMPARATOR

Moxifloxacin tablet

Drug: Moxifloxacin

Interventions

Single-Dose IV Oritavancin Diphosphate DRUG

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

Also known as: Oritavancin Diphosphate

Oritavancin

Placebo DRUG

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

Placebo

Moxifloxacin DRUG

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

Also known as: Avelox

Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to give written informed consent before initiation of any study related procedures and willing to comply with all required study procedures.
• Healthy, male and female between 18 and 60 years old, body mass index between 18 and 30 kilograms/meter squared.
• In good health based upon results of medical history, physical examination, no clinically significant 12-lead electrocardiogram (ECG) results, and laboratory test results.
• Serum magnesium and potassium levels within the normal range at Screening.
• 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.

You may not qualify if:

• 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.
• A resting pulse rate \< 50 beats per minute (bpm) or \> 100 bpm.
• Systolic blood pressure \< 90 millimeters of mercury (mmHg) or diastolic blood pressure \< 50 mmHg.
• A QTc with the Fridericia correction \> 450 microseconds (msec) (males) or \> 470 msec (females).
• Respiratory difficulties, or a history of asthma or chronic obstructive pulmonary disease.
• 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).
• Unwilling to abstain from smoking for the duration of the study.
• 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.
• Positive result for the urine or serum human chorionic gonadotropin test administered at Screening (females with childbearing potential).
• 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.
• Personal history of unexplained syncope.
• A history of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents.
• Positive virology screen for human immunodeficiency virus or hepatitis B or C virus, respectively.
• Participated in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment.
• Any condition, which in the opinion of the Investigator would put the participant at increased risk from participating in the study.

Sponsors & Collaborators

• Melinta Therapeutics, Inc.: lead

Study Sites (1)

Spaulding Clinical

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Carlos Sanabria, MD

  Spaulding Clinical

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: January 8, 2013
• Study Start: December 27, 2012
• Primary Completion: January 1, 2013
• Study Completion: February 11, 2013
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

US (1)