Study to Evaluate the Effect of Naltrexone and Bupropion Extended-Release Combination on Cardiac Repolarization in Healthy Participants

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the potential effect of naltrexone and bupropion extended-release combination on cardiac repolarization in healthy participants.

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

Details

• Lead Sponsor: Orexigen Therapeutics, Inc
• Treatments: Bupropion; Bupropion hydrochloride, naltrexone hydrochoride drug combination; Fluoroquinolones; Moxifloxacin; Naltrexone; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

1. Is a healthy male or female.

2. Is aged 18 to 55 years, inclusive, at signing of informed consent and first dose of study drug.

3. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) of 18.0 to 35.0 kilogram per square meter (kg/m^2), inclusive, at screening.

Exclusion Criteria:

1. Has known hypersensitivity to moxifloxacin or other quinolone antibiotics or any component of the formulation of naltrexone/bupropion.

2. Has a history of seizure of any etiology, or of predisposition to seizures.

3. Has a history of significant cardiac disease.

4. Has a history of bulimia.

5. Has a history of anorexia nervosa.

6. Has a hemoglobin concentration less than (<) 12 gram per deciliter (g/dL) at screening or check-in (day -2) of period 1.

7. Has resting heart rate outside the normal range of 45 to 100 beats per minute at screening or check-in (day -2) of period 1.

8. Has orthostatic blood pressure greater than or equal to (>=) 25 millimeters of mercury (mm Hg) at screening or check-in (day -2) of period 1.

9. Has sustained supine systolic blood pressure >=140 mm Hg or <=90 mm Hg or a diastolic blood pressure >=90 mm Hg or <=50 mm Hg at screening or check-in (day -2) of period 1.

10. Has abnormal screening or check-in (day -2) of period 1 ECG indicating a second- or third-degree atrioventricular block, or 1 or more of the following: PR >220 msec, QRS >120 msec, and QTcF >450 msec, or any rhythm other than sinus rhythm that is interpreted by the investigator to be clinically significant or could interfere with an accurate measurement of the QT interval.

11. Has family history of long QT syndrome.

12. Had extensive exercising in normal life, for example, marathon running, triathlon, physical sports at a contest level.