Study to examine safety, tolerability & PK of Baclofen and Memantine
Research type
Research Study
Full title
A Study to Examine the Safety, Tolerability and Pharmacokinetics of Co-Administered Baclofen and Memantine in Obese and Lean, Otherwise Healthy Adults
IRAS ID
137514
Contact name
Timothy G K Mant
Contact email
Sponsor organisation
Gedeon Richter Plc.
Eudract number
2013-002877-23
Research summary
The purpose of this study is to investigate the safety and tolerability of the combination of the two marketed medications Baclofen and Memantine when given to healthy volunteers.
This will be the first time a combination of Memantine and Baclofen will be given together in a clinical study.
This study will be conducted in two parts (Part A and Part B). Part A will be done in Lean Healthy Subjects (Body Mass Index (BMI) of between 18-25 kg/m²) and Part B will be done in Obese Healthy Subjects (BMI of between 33-40 kg/m²).
Part A will involve 16 (8 males and 8 females) Lean healthy subjects and Part B will involve 36 (18 males and 18 females) Obese healthy subjects.
Part A will be open label, all the volunteers will receive study drug.
Part B will be double-blind, so neither volunteers nor investigators will know whether individual volunteer receives study drug or placebo (dummy drug). In Part B, volunteers will be randomly assigned to either study drug or placebo in a ratio of 2:1.
We will look at the way the body absorbs, distributes breaks down and eliminates the drugs (the pharmacokinetic parameters) and whether the levels of the drugs in the blood differ between Obese Healthy Subjects compared with Lean Healthy Subjects.
The study will take place over approximately 14 weeks and involve 2 residential periods where they will not be allowed to leave the unit; a 6 day/ 5 night stay followed at least 17 days later by a 27 day/ 26 night stay.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
13/NW/0610
Date of REC Opinion
2 Oct 2013
REC opinion
Further Information Favourable Opinion