Status:
COMPLETED
Study to Evaluate the Effect of Naltrexone and Bupropion Combination on the Pharmacokinetics of Metformin in Healthy Participants
Lead Sponsor:
Orexigen Therapeutics, Inc
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the effect of multiple oral doses of naltrexone/bupropion on the pharmacokinetics (PK) of a single oral dose of metformin.
Detailed Description
The drug being tested in this study is naltrexone HCl and bupropion HCl Extended- Release fixed dose combination (NB) . This study will evaluate the potential effect of multiple oral doses of extended...
Eligibility Criteria
Inclusion
- 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 40.0 kilogram per square meter (kg/m\^2), inclusive, at Screening.
- Has normal renal function (defined as CrCl \>=90 mL/min/1.73 m\^2) at Screening and Check-in (Day -1).
- A female subject of childbearing potential\* who is sexually active with a nonsterilized\* male partner agrees to use adequate contraception\* from signing of informed consent throughout the duration of the study and for 12 weeks after the last dose of study drug.
Exclusion
- Has known hypersensitivity to metformin, bupropion, naltrexone, or any component of the formulations.
- Has history of seizure of any etiology, or of predisposition to seizures.
- Has history of bulimia.
- Has history of anorexia nervosa.
- Has resting heart rate outside the normal range of 45 to 100 beats per minutes at Screening or Check-in (Day -1) and confirmed by a repeat measurement approximately 30 minutes following the initial measurement.
- Has orthostatic blood pressure \>=25 millimeter of mercury (mm Hg) at Screening or Check-in (Day -1) and confirmed by a repeat measurement approximately 30 minutes following the initial measurement.
- Has sustained supine systolic blood pressure \>=140 mm Hg or less than equal to (\<=) 90 mm Hg or a diastolic blood pressure \>=90 mm Hg or \<=50 mm Hg at Screening or Check-in (Day -1) and confirmed by a repeat measurement approximately 30 minutes following the initial measurement.
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02745912
Start Date
April 1 2016
End Date
August 1 2016
Last Update
September 29 2016
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