NCT02735603

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

April 5, 2016

Last Update Submit

October 31, 2016

Conditions

Heart Repolarization

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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 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 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

    Baseline and Day 11

  • QTcF, QTcB, QTcI, and QT intervals >450 msec, >480 msec or >500 msec at Day 11

    Day 11

  • +4 more secondary outcomes

Study Arms (6)

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.

Drug: Naltrexone HCl/bupropion HClOther: PlaceboDrug: 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.

Drug: Naltrexone HCl/bupropion HClOther: PlaceboDrug: 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.

Drug: Naltrexone HCl/bupropion HClOther: PlaceboDrug: 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.

Drug: Naltrexone HCl/bupropion HClOther: PlaceboDrug: 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.

Drug: Naltrexone HCl/bupropion HClOther: PlaceboDrug: 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.

Drug: Naltrexone HCl/bupropion HClOther: PlaceboDrug: Moxifloxacin

Interventions

Naltrexone HCl/bupropion HClDRUG

Naltrexone HCl/bupropion HCl extended-release tablet.

Moxifloxacin + Naltrexone/Bupropion + PlaceboMoxifloxacin + Placebo + Naltrexone/BupropionNalterxone/Bupropion + Placebo + MoxifloxacinNaltrexone/Bupropion + Moxifloxacin + PlaceboPlacebo + Moxifloxacin + Naltrexone/BupropionPlacebo + Naltrexone/Bupropion + Moxifloxacin
PlaceboOTHER

Naltrexone/bupropion placebo-matching tablets.

Moxifloxacin + Naltrexone/Bupropion + PlaceboMoxifloxacin + Placebo + Naltrexone/BupropionNalterxone/Bupropion + Placebo + MoxifloxacinNaltrexone/Bupropion + Moxifloxacin + PlaceboPlacebo + Moxifloxacin + Naltrexone/BupropionPlacebo + Naltrexone/Bupropion + Moxifloxacin
MoxifloxacinDRUG

Moxifloxacin tablet.

Moxifloxacin + Naltrexone/Bupropion + PlaceboMoxifloxacin + Placebo + Naltrexone/BupropionNalterxone/Bupropion + Placebo + MoxifloxacinNaltrexone/Bupropion + Moxifloxacin + PlaceboPlacebo + Moxifloxacin + Naltrexone/BupropionPlacebo + Naltrexone/Bupropion + Moxifloxacin

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Austin, Texas, United States

Location

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Medical Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 12, 2016

Study Start

April 1, 2016

Primary Completion

July 1, 2016

Study Completion

October 1, 2016

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

US(1)