A Phase 1, Open-Label, Sequential Design Study to Evaluate the Potential Effect of Multiple Oral Doses of Extended-Release Combination of Naltrexone and Bupropion on the Pharmacokinetics of a Single Oral Dose of Metformin in Healthy Subjects

NCT02745912 Phase 1 COMPLETED

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.

Details

Lead sponsor	Orexigen Therapeutics, Inc
Phase	Phase 1
Status	COMPLETED
Enrolment	30
Start date	2016-04
Completion	2016-08

Conditions

• Healthy Subjects

Interventions

• Naltrexone/Bupropion
• Metformin

Primary outcomes

• Cmax: Maximum Observed Plasma Concentration for Metformin Following a Single Dose of Metformin Administered Alone — Day 1: predose and at multiple timepoints (up to 48 hours) post-dose
• Cmax: Maximum Observed Plasma Concentration of Metformin Following a Single Dose of Metformin and multiple Doses of naltrexone/bupropion — Day 14: predose and at multiple timepoints (up to 48 hours) post-dose
• AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity of Metformin Following a Single Dose of Metformin Administered Alone — Day 1: predose and at multiple timepoints (up to 48 hours) post-dose
• AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity of Metformin Following a Single Dose of Metformin and Multiple Doses of naltrexone/bupropion — Day 14: predose and at multiple timepoints (up to 48 hours) post-dose