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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to generate cardiac safety data using a supratherapeutic oritavancin dose of 1600 mg.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Medicines Company
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Oritavancin

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, BMI between 18 kg/m2 and 30 kg/m2

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

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

5. Agree 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: patients who have had histamine-like infusion reactions to a glycopeptide are not excluded

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

3. Systolic blood pressure < 90 mmHg or diastolic blood pressure < 50 mmHg

4. A QTcF >450 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 (OTC) medications or herbal preparations within 14 days or 5-times the elimination half-life (whichever is 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 interfere with the interpretation of QTc interval changes

9. Positive result for the urine or serum human chorionic gonadotropin (hCG) test administered at screening (females with child bearing 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 are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 acceptable methods of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier method(s) or male partner sterilization). Women ≥2 years postmenopausal or surgically sterile are 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 (HIV) or hepatitis B or C virus (HBV or HCV, 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 subject at increased risk from participating in the study.