Study to Evaluate the Effect of Naltrexone and Bupropion Extended-Release Combination on Cardiac Repolarization in Healthy Participants
NCT ID: NCT02735603
Last Updated: 2016-11-01
Study Results
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Basic Information
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COMPLETED
PHASE1
84 participants
INTERVENTIONAL
2016-04-30
2016-10-31
Brief Summary
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Detailed Description
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The study will enroll approximately 84 participants. Participants will be randomly assigned (by chance, like flipping a coin) to 1 of 6 treatment sequences, which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
* Naltrexone/Bupropion + Placebo + Moxifloxacin
* Placebo + Moxifloxacin + Naltrexone/Bupropion
* Moxifloxacin + Naltrexone/Bupropion + Placebo
* Naltrexone/Bupropion + Moxifloxacin + Placebo
* Placebo + Naltrexone/Bupropion + Moxifloxacin
* Moxifloxacin + Placebo + Naltrexone/Bupropion
This study is consisted of 3 periods separated by a washout period (Days 11 through 25). Participants will be admitted to the clinic on Day -2 (Check-in) of each study period and will remain confined to the clinic until the morning of Day 12 of each study period. On Day -1 and Day 11 of each period, participants will undergo 24 hour Holter recordings using an ambulatory electrocardiograph recorder.
This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 96 days.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
QUADRUPLE
Study Groups
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Nalterxone/Bupropion + Placebo + Moxifloxacin
Naltrexone hydrochloride (HCl) 8 milligram (mg)/bupropion HCl 90 mg (NB) placebo-matching 2 tablets, orally, once in the morning on Day -1, NB, 1 extended-release tablet, orally, twice daily and NB placebo-matching 1 tablet, orally, twice daily from Days 1 to 3, NB, 2 extended-release tablets, orally, twice daily from Days 4 to 10 and once in the morning on Day 11 in treatment period 1, followed by 14 days washout period, followed by NB placebo-matching 2 tablets, orally, once in the morning on Day -1, twice daily from Days 1 to 10, and once in the morning on Day 11 in treatment period 2, followed by 14 days washout period, followed by NB placebo-matching 2 tablets, orally, once in the morning on Day -1, twice daily from Days 1 to 10, moxifloxacin 400 mg, tablet, orally, once in the morning on Day 11 in treatment period 3.
Naltrexone HCl/bupropion HCl
Naltrexone HCl/bupropion HCl extended-release tablet.
Placebo
Naltrexone/bupropion placebo-matching tablets.
Moxifloxacin
Moxifloxacin tablet.
Placebo + Moxifloxacin + Naltrexone/Bupropion
NB placebo-matching 2 tablets, orally, once in the morning on Day -1, twice daily from Days 1 to 10 and once in the morning on Day 11 in treatment period 1, followed by 14 days washout period, followed by NB placebo-matching 2 tablets, orally, once in the morning on Day -1, twice daily from Days 1 to 10, moxifloxacin 400 mg, tablet, orally, once in the morning on Day 11 in treatment period 2, followed by 14 days washout period, followed by NB placebo-matching 2 tablets, orally, once in the morning on Day -1, NB, 1 extended-release tablet, orally, twice daily and NB placebo-matching 1 tablet, orally, twice daily from Days 1 to 3, NB, 2 extended-release tablets, orally, twice daily from Days 4 to 10 and once in the morning on Day 11 in treatment period 3.
Naltrexone HCl/bupropion HCl
Naltrexone HCl/bupropion HCl extended-release tablet.
Placebo
Naltrexone/bupropion placebo-matching tablets.
Moxifloxacin
Moxifloxacin tablet.
Moxifloxacin + Naltrexone/Bupropion + Placebo
NB placebo-matching 2 tablets, orally, once in the morning on Day -1, twice daily from Days 1 to 10, moxifloxacin 400 mg, tablet, orally, once in the morning on Day 11 in treatment period 1, followed by 14 days washout period, followed by NB placebo-matching 2 tablets, orally, once in the morning on Day -1, NB, 1 extended-release tablet, orally, twice daily and NB placebo-matching 1 tablet, orally, twice daily from Days 1 to 3, NB, 2 extended-release tablets, orally, twice daily from Day 4 to 10, and once in the morning on Day 11 in treatment period 2, followed by 14 days washout period, followed by NB placebo-matching 2 tablets, orally, once in the morning on Day -1, twice daily from Days 1 to 10 and once in the morning on Day 11 in the treatment period 3.
Naltrexone HCl/bupropion HCl
Naltrexone HCl/bupropion HCl extended-release tablet.
Placebo
Naltrexone/bupropion placebo-matching tablets.
Moxifloxacin
Moxifloxacin tablet.
Naltrexone/Bupropion + Moxifloxacin + Placebo
NB placebo-matching 2 tablets, orally, once in the morning on Day -1, NB, 1 extended-release tablet, orally, twice daily and NB placebo-matching 1 tablet, orally, twice daily from Days 1 to 3, NB, 2 extended-release tablets, orally, twice daily from Days 4 to 10 and once in the morning on Day 11 in treatment period 1, followed by 14 days washout period, followed by NB placebo-matching 2 tablets, orally, once in the morning on Day -1, twice daily from Days 1 to 10, moxifloxacin 400 mg, tablet, orally, once in the morning on Day 11 in treatment period 2 followed by 14 days washout period, followed by NB placebo-matching 2 tablets, orally, once in the morning on Day -1, twice daily from Days 1 to 10 and once in the morning on Day 11 in treatment period 3.
Naltrexone HCl/bupropion HCl
Naltrexone HCl/bupropion HCl extended-release tablet.
Placebo
Naltrexone/bupropion placebo-matching tablets.
Moxifloxacin
Moxifloxacin tablet.
Placebo + Naltrexone/Bupropion + Moxifloxacin
NB placebo-matching 2 tablets, orally, once in the morning on Day -1, twice daily from Days 1 to 10 and once in the morning on Day 11 in treatment period 1, followed by 14 days washout period, followed by NB placebo-matching 2 tablets, orally, once in the morning on Day -1, NB, 1 extended-release tablet, orally, twice daily and NB placebo-matching 1 tablet, orally, twice daily from Days 1 to 3, NB, 2 extended-release tablets, orally, twice daily from Days 4 to 10 and once in the morning on Day 11 in treatment period 2 followed by 14 days washout period, followed by NB placebo-matching 2 tablets, orally, once in the morning on Day -1, twice daily from Days 1 to 10, moxifloxacin 400 mg, tablet, orally, once in the morning on Day 11 in treatment period 3.
Naltrexone HCl/bupropion HCl
Naltrexone HCl/bupropion HCl extended-release tablet.
Placebo
Naltrexone/bupropion placebo-matching tablets.
Moxifloxacin
Moxifloxacin tablet.
Moxifloxacin + Placebo + Naltrexone/Bupropion
NB placebo-matching 2 tablets, orally, once in the morning on Day -1, twice daily from Days 1 to 10, moxifloxacin 400 mg, tablet, orally, once in the morning on Day 11 in treatment period 1 followed by 14 days washout period, followed by NB placebo-matching 2 tablets, orally, once in the morning on Day -1, twice daily from Days 1 to 10 and once in the morning on Day 11 in treatment period 2 followed by 14 days washout period, followed by NB placebo-matching 2 tablets, orally, once in the morning on Day -1, NB, 1 extended-release tablet, orally, twice daily and NB placebo-matching 1 tablet, orally, twice daily from Days 1 to 3, NB, 2 extended-release tablets, orally, twice daily from Days 4 to 10 and once in the morning on Day 11 in treatment period 3.
Naltrexone HCl/bupropion HCl
Naltrexone HCl/bupropion HCl extended-release tablet.
Placebo
Naltrexone/bupropion placebo-matching tablets.
Moxifloxacin
Moxifloxacin tablet.
Interventions
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Naltrexone HCl/bupropion HCl
Naltrexone HCl/bupropion HCl extended-release tablet.
Placebo
Naltrexone/bupropion placebo-matching tablets.
Moxifloxacin
Moxifloxacin tablet.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
55 Years
ALL
Yes
Sponsors
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Orexigen Therapeutics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Austin, Texas, United States
Countries
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Other Identifiers
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U1111-1171-3290
Identifier Type: REGISTRY
Identifier Source: secondary_id
NaltrexBuprop-1001
Identifier Type: -
Identifier Source: org_study_id