Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT02735603
Eligibility 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02735603
Study Brief:
Protocol Section:
NCT02735603