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

Completed · Phase 1 · Has a placebo group

Conditions studied: Heart Repolarization

In brief

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

Key facts

Study ID

NCT02735603

Run by

Orexigen Therapeutics, Inc

People needed

84

Starts

2016-04-01

Expected to finish

2016-10-01

Last updated by the study team

2016-11-01

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Is a healthy male or female.
• Is aged 18 to 55 years, inclusive, at signing of informed consent and first dose of study drug.
• 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.

You may not qualify if…

• Has known hypersensitivity to moxifloxacin or other quinolone antibiotics or any component of the formulation of naltrexone/bupropion.
• Has a history of seizure of any etiology, or of predisposition to seizures.
• Has a history of significant cardiac disease.
• Has a history of bulimia.
• Has a history of anorexia nervosa.
• Has a hemoglobin concentration less than (<) 12 gram per deciliter (g/dL) at screening or check-in (day -2) of period 1.
• 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.
• 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.
• 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.
• 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.
• Has family history of long QT syndrome.
• Had extensive exercising in normal life, for example, marathon running, triathlon, physical sports at a contest level.

Where it is running

• Study site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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