Healthy Volunteers; Clinical Trial
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 18 Years to 45 Years |
| Eligibility |
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. |
N/A
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Quintiles Drug Research Unit at Guy's Hospital | London |
| Lead Sponsor | Collaborator |
|---|---|
| Gedeon Richter Plc. |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety and tolerability of co-administered baclofen and memantine via C-SSRS | From Baseline until Follow-up | ||
| Primary | Safety and tolerability of co-administered baclofen and memantine via Adverse Events | From Baseline until Follow-up | ||
| Primary | Safety and tolerability of co-administered baclofen and memantine via Vital Signs | From Baseline until Follow-up | ||
| Primary | Safety and tolerability of co-administered baclofen and memantine via ECG | From Baseline until Follow-up | ||
| Primary | Safety and tolerability of co-administered baclofen and memantine via Clinical Laboratory Tests | From Baseline until Follow-up | ||
| Secondary | Pharmacokinetic parameters of co-administered baclofen and memantine via Cmax | From Baseline until Day 32 | ||
| Secondary | Pharmacokinetic parameters of co-administered baclofen and memantine via Tmax | From Baseline until Day 32 | ||
| Secondary | Pharmacokinetic parameters of co-administered baclofen and memantine via AUC | From Baseline until Day 32 | ||
| Secondary | Pharmacokinetic parameters of co-administered baclofen and memantine via MRT | From Baseline until Day 32 | ||
| Secondary | Pharmacokinetic parameters of co-administered baclofen and memantine via CL/F | From Baseline until Day 32 | ||
| Secondary | Pharmacokinetic parameters of co-administered baclofen and memantine via T1/2 | From Baseline until Day 32 | ||
| Secondary | Pharmacokinetic parameters of co-administered baclofen and memantine via CLR | From Baseline until Day 32 |