Clinical trial NCT02001584: A Study to Examine the, Safety, Tolerability and Pharmacokinetics Co-Administered Baclofen and Memantine in Obese and Lean, Otherwise Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers;
Obese, Otherwise Healthy Volunteers
Lead sponsor: Gedeon Richter Plc.
Sponsor class: INDUSTRY
First posted: 2013-12-05
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT

Brief summary: The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of a predefined dose range of co-administered Baclofen and Memantine in non-obese (Part A) and obese (Part B), otherwise healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Adult males or females aged 18 to 45 years inclusive;
2. Subjects with body mass index:

   For Part A: ≥18 kg/m² and ≤25 kg/m²; For Part B: ≥33 kg/m² and ≤40 kg/m².
3. Subjects with a total body weight of ≥50 kg (Part A and Part B);
4. Subjects who are healthy as determined by the Investigator based on pre study medical history, physical examination, vital signs (blood pressure, pulse rate, respiratory rate and body temperature) and 12-lead ECG at screening and each admission;
5. Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the Investigator at screening and each admission;
6. Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and bilirubin ≤1.5 x upper limit of normal (ULN);
7. Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening;
8. Subjects who are negative for drugs of abuse and alcohol tests at screening and each admission;
9. Subjects who are non-smokers or who have not smoked or used nicotine-containing products for at least 3 months prior to screening;
10. Subjects with an estimated creatinine clearance ≥100 mL/minute for male subjects or

    ≥90 mL/minute for female subjects (Cockcroft-Gault method) at screening;
11. Subjects who are able and willing to give written informed consent.

Primary outcomes:
measure: Safety and tolerability of co-administered baclofen and memantine via C-SSRS
timeFrame: From Baseline until Follow-up
measure: Safety and tolerability of co-administered baclofen and memantine via Adverse Events
timeFrame: From Baseline until Follow-up
measure: Safety and tolerability of co-administered baclofen and memantine via Vital Signs
timeFrame: From Baseline until Follow-up
measure: Safety and tolerability of co-administered baclofen and memantine via ECG
timeFrame: From Baseline until Follow-up
measure: Safety and tolerability of co-administered baclofen and memantine via Clinical Laboratory Tests
timeFrame: From Baseline until Follow-up
Secondary outcomes:
measure: Pharmacokinetic parameters of co-administered baclofen and memantine via Cmax
timeFrame: From Baseline until Day 32
measure: Pharmacokinetic parameters of co-administered baclofen and memantine via Tmax
timeFrame: From Baseline until Day 32
measure: Pharmacokinetic parameters of co-administered baclofen and memantine via AUC
timeFrame: From Baseline until Day 32
measure: Pharmacokinetic parameters of co-administered baclofen and memantine via MRT
timeFrame: From Baseline until Day 32
measure: Pharmacokinetic parameters of co-administered baclofen and memantine via CL/F
timeFrame: From Baseline until Day 32
measure: Pharmacokinetic parameters of co-administered baclofen and memantine via T1/2
timeFrame: From Baseline until Day 32
measure: Pharmacokinetic parameters of co-administered baclofen and memantine via CLR
timeFrame: From Baseline until Day 32
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Quintiles Drug Research Unit at Guy's Hospital
Study officials:
References: