Heart RepolarizationPhase 1NCT02735603
Study to Evaluate the Effect of Naltrexone and Bupropion Extended-Release Combination on Cardiac Repolarization in Healthy Participants
A Phase 1 study testing Naltrexone HCl/bupropion HCl and Moxifloxacin in people with Heart Repolarization, run by Orexigen Therapeutics, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Repolarization
- What is being tested?
- Naltrexone HCl/bupropion HCl and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Oct 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo- and Moxifloxacin Positive-Controlled (Open-Label), Cross-Over Study to Evaluate the Potential Effect of Naltrexone and Bupropion Extended-Release Combination on Cardiac Repolarization in Healthy Subjects
The purpose of this study is to evaluate the potential effect of naltrexone and bupropion extended-release combination on cardiac repolarization in healthy participants.
Read the detailed description
The drug being tested in this study is called naltrexone HCl/bupropion HCl (NB). NB is approved by the U.S. Food and Drug Administration (FDA) in addition to a reduced-calorie diet and increased physical activity for chronic weight management in adults who are obese or who are overweight and have at least one additional weight-related condition such as high blood pressure, diabetes or high cholesterol. This study is conducted to determine the potential effect of NB relative to placebo on cardiac repolarization.
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
- Heart Repolarization
- Being tested
- Naltrexone HCl/bupropion HCl, Placebo, Moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone HCl/bupropion HClDrug
Naltrexone HCl/bupropion HCl extended-release tablet.
PlaceboOther
Naltrexone/bupropion placebo-matching tablets.
MoxifloxacinDrug
Moxifloxacin tablet.
| Study group | Role | What they receive |
|---|---|---|
| Nalterxone/Bupropion + Placebo + Moxifloxacin | Experimental | 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. Receives: Drug: Naltrexone HCl/bupropion HCl; Other: Placebo; Drug: Moxifloxacin |
| Placebo + Moxifloxacin + Naltrexone/Bupropion | Experimental | 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. Receives: Drug: Naltrexone HCl/bupropion HCl; Other: Placebo; Drug: Moxifloxacin |
| Moxifloxacin + Naltrexone/Bupropion + Placebo | Experimental | 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. Receives: Drug: Naltrexone HCl/bupropion HCl; Other: Placebo; Drug: Moxifloxacin |
| Naltrexone/Bupropion + Moxifloxacin + Placebo | Experimental | 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. Receives: Drug: Naltrexone HCl/bupropion HCl; Other: Placebo; Drug: Moxifloxacin |
| Placebo + Naltrexone/Bupropion + Moxifloxacin | Experimental | 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. Receives: Drug: Naltrexone HCl/bupropion HCl; Other: Placebo; Drug: Moxifloxacin |
| Moxifloxacin + Placebo + Naltrexone/Bupropion | Experimental | 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. Receives: Drug: Naltrexone HCl/bupropion HCl; Other: Placebo; Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time-matched change from Baseline in QT interval with Fridericia correction method (QTcF)
QT and RR intervals will be recorded using ECG machines. Fridericia correction method is calculated by dividing QT interval by the cube root of the RR interval: QTcF = QT/RR^1/3.
Measured: Time matched Baseline and Day 11 within 30 minutes predose and up to 23.5 hours postdose
Secondary outcomes (9)
Time-Matched Change From Baseline in QT Interval With Bazett Correction Method (QTcB) at Day 11
QT and RR intervals will be recorded using ECG machines. QTcB will be calculated by dividing QT interval by the square root of the RR interval: QTcB = QT/RR^1/2.
Measured: Time matched baseline and at multiple time-points (up to 23.5 hours) postdose on Day 11
Time-Matched Change From Baseline in QT Interval With Individual Correction Method (QTcI) at Day 11
QT and RR intervals will be recorded using ECG machines. QTcI will be calculated as QT/RR^beta, where the value of beta will be calculated using linear regression modeling for each subject on all baseline QT - RR interval pairs.
Measured: Time matched baseline and at multiple time-points (up to 23.5 hours) postdose on Day 11
Time-Matched Change From Baseline in Uncorrected QT at Day 11
Measured: Time matched baseline and at multiple time-points (up to 23.5 hours) postdose on Day 11
Time-Matched Increases From Baseline in QTcF, QTcB, QTcI, and QT > 30 msec and > 60 msec at Day 11
QTcF will be calculated by dividing QT interval by the cube root of the RR interval: QTcF= QT/RR^1/3. QTcB will be calculated by dividing QT interval by the square root of the RR interval: QTcB = QT/RR^1/2. QTcI will be calculated as as QT/RR^beta, where the value of beta will be calculated using linear regression modeling for each subject on all baseline QT - RR interval pairs
Measured: Baseline and Day 11
QTcF, QTcB, QTcI, and QT intervals >450 msec, >480 msec or >500 msec at Day 11
QTcF will be calculated by dividing QT interval by the cube root of the RR interval: QTcF= QT/RR^1/3. QTcB will be calculated by dividing QT interval by the square root of the RR interval: QTcB = QT/RR^1/2. QTcI will be calculated as QT/RR^beta., where the value of beta will be calculated using linear regression modeling for each subject on all baseline QT - RR interval pairs.
Measured: Day 11
T-U wave complex morphology on Day 11
Measured: Day 11
Cmax- Maximum Observed Plasma Concentration for Naltrexone, Bupropion, and their Metabolites
Measured: Day 11: predose and at multiple time points (up to 23.5 hours) postdose
Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Naltrexone, Bupropion, and their Metabolites
Measured: Day 11: predose and at multiple time points (up to 23.5 hours) postdose
9. Percentage of Participants Reporting at least one Treatment-Emergent Adverse Event (TEAE)
Measured: Baseline up to 30 days after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart RepolarizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orexigen Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735603
- Sponsor's protocol ID
- NaltrexBuprop-1001
- Other IDs
- U1111-1171-3290
- Status last verified
- Oct 2016
- First submitted
- 5 Apr 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Moxifloxacin Positive-Controlled (Open-Label), Cross-Over Study to Evaluate the Potential Effect of Naltrexone and Bupropion Extended-Release Combination on Cardiac Repolarization in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02735603
- Acronym / sponsor ID
- NaltrexBuprop-1001
- Conditions
- Heart Repolarization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Orexigen Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the potential effect of naltrexone and bupropion extended-release combination on cardiac repolarization in healthy participants.
Detailed description
The drug being tested in this study is called naltrexone HCl/bupropion HCl (NB). NB is approved by the U.S. Food and Drug Administration (FDA) in addition to a reduced-calorie diet and increased physical activity for chronic weight management in adults who are obese or who are overweight and have at least one additional weight-related condition such as high blood pressure, diabetes or high cholesterol. This study is conducted to determine the potential effect of NB relative to placebo on cardiac repolarization.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Nalterxone/Bupropion + Placebo + Moxifloxacin | Experimental | Drug: Naltrexone HCl/bupropion HCl, Other: Placebo, Drug: MoxifloxacinNaltrexone 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. |
| Placebo + Moxifloxacin + Naltrexone/Bupropion | Experimental | Drug: Naltrexone HCl/bupropion HCl, Other: Placebo, Drug: MoxifloxacinNB 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. |
| Moxifloxacin + Naltrexone/Bupropion + Placebo | Experimental | Drug: Naltrexone HCl/bupropion HCl, Other: Placebo, Drug: MoxifloxacinNB 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/Bupropion + Moxifloxacin + Placebo | Experimental | Drug: Naltrexone HCl/bupropion HCl, Other: Placebo, Drug: MoxifloxacinNB 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. |
| Placebo + Naltrexone/Bupropion + Moxifloxacin | Experimental | Drug: Naltrexone HCl/bupropion HCl, Other: Placebo, Drug: MoxifloxacinNB 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. |
| Moxifloxacin + Placebo + Naltrexone/Bupropion | Experimental | Drug: Naltrexone HCl/bupropion HCl, Other: Placebo, Drug: MoxifloxacinNB 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone HCl/bupropion HClNaltrexone HCl/bupropion HCl extended-release tablet. | Drug | Moxifloxacin + Naltrexone/Bupropion + Placebo, Moxifloxacin + Placebo + Naltrexone/Bupropion, Nalterxone/Bupropion + Placebo + Moxifloxacin, Naltrexone/Bupropion + Moxifloxacin + Placebo, Placebo + Moxifloxacin + Naltrexone/Bupropion, Placebo + Naltrexone/Bupropion + Moxifloxacin |
| PlaceboNaltrexone/bupropion placebo-matching tablets. | Other | Moxifloxacin + Naltrexone/Bupropion + Placebo, Moxifloxacin + Placebo + Naltrexone/Bupropion, Nalterxone/Bupropion + Placebo + Moxifloxacin, Naltrexone/Bupropion + Moxifloxacin + Placebo, Placebo + Moxifloxacin + Naltrexone/Bupropion, Placebo + Naltrexone/Bupropion + Moxifloxacin |
| MoxifloxacinMoxifloxacin tablet. | Drug | Moxifloxacin + Naltrexone/Bupropion + Placebo, Moxifloxacin + Placebo + Naltrexone/Bupropion, Nalterxone/Bupropion + Placebo + Moxifloxacin, Naltrexone/Bupropion + Moxifloxacin + Placebo, Placebo + Moxifloxacin + Naltrexone/Bupropion, Placebo + Naltrexone/Bupropion + Moxifloxacin |
Primary outcome
The time-matched change from Baseline in QT interval with Fridericia correction method (QTcF)
Time frame: Time matched Baseline and Day 11 within 30 minutes predose and up to 23.5 hours postdose
QT and RR intervals will be recorded using ECG machines. Fridericia correction method is calculated by dividing QT interval by the cube root of the RR interval: QTcF = QT/RR^1/3.
9 secondary outcomes
Time-Matched Change From Baseline in QT Interval With Bazett Correction Method (QTcB) at Day 11
Time frame: Time matched baseline and at multiple time-points (up to 23.5 hours) postdose on Day 11
Time-Matched Change From Baseline in QT Interval With Individual Correction Method (QTcI) at Day 11
Time frame: Time matched baseline and at multiple time-points (up to 23.5 hours) postdose on Day 11
Time-Matched Change From Baseline in Uncorrected QT at Day 11
Time frame: Time matched baseline and at multiple time-points (up to 23.5 hours) postdose on Day 11
Time-Matched Increases From Baseline in QTcF, QTcB, QTcI, and QT > 30 msec and > 60 msec at Day 11
Time frame: Baseline and Day 11
QTcF, QTcB, QTcI, and QT intervals >450 msec, >480 msec or >500 msec at Day 11
Time frame: Day 11
T-U wave complex morphology on Day 11
Time frame: Day 11
Cmax- Maximum Observed Plasma Concentration for Naltrexone, Bupropion, and their Metabolites
Time frame: Day 11: predose and at multiple time points (up to 23.5 hours) postdose
Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Naltrexone, Bupropion, and their Metabolites
Time frame: Day 11: predose and at multiple time points (up to 23.5 hours) postdose
9. Percentage of Participants Reporting at least one Treatment-Emergent Adverse Event (TEAE)
Time frame: Baseline up to 30 days after the last dose of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naltrexone HCl/bupropion HCl and Moxifloxacin in people with Heart Repolarization, run by Orexigen Therapeutics, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time-matched change from Baseline in QT interval with Fridericia correction method (QTcF) (time frame: Time matched Baseline and Day 11 within 30 minutes predose and up to 23.5 hours postdose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.