A Study to Examine the, Safety, Tolerability and Pharmacokinetics Co-Administered Baclofen and Memantine in Obese and Lean, Otherwise Healthy Adults
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Healthy Volunteers
|
Drug: Baclofen
Drug: Memantine
|
| Experimental: Obese, Otherwise Healthy Volunteers
|
Drug: Baclofen
Drug: Memantine
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Safety and tolerability of co-administered baclofen and memantine via C-SSRS [From Baseline until Follow-up]
- Safety and tolerability of co-administered baclofen and memantine via Adverse Events [From Baseline until Follow-up]
- Safety and tolerability of co-administered baclofen and memantine via Vital Signs [From Baseline until Follow-up]
- Safety and tolerability of co-administered baclofen and memantine via ECG [From Baseline until Follow-up]
- Safety and tolerability of co-administered baclofen and memantine via Clinical Laboratory Tests [From Baseline until Follow-up]
Secondary Outcome Measures
- Pharmacokinetic parameters of co-administered baclofen and memantine via Cmax [From Baseline until Day 32]
- Pharmacokinetic parameters of co-administered baclofen and memantine via Tmax [From Baseline until Day 32]
- Pharmacokinetic parameters of co-administered baclofen and memantine via AUC [From Baseline until Day 32]
- Pharmacokinetic parameters of co-administered baclofen and memantine via MRT [From Baseline until Day 32]
- Pharmacokinetic parameters of co-administered baclofen and memantine via CL/F [From Baseline until Day 32]
- Pharmacokinetic parameters of co-administered baclofen and memantine via T1/2 [From Baseline until Day 32]
- Pharmacokinetic parameters of co-administered baclofen and memantine via CLR [From Baseline until Day 32]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult males or females aged 18 to 45 years inclusive;
-
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.
-
Subjects with a total body weight of ≥50 kg (Part A and Part B);
-
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;
-
Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the Investigator at screening and each admission;
-
Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and bilirubin ≤1.5 x upper limit of normal (ULN);
-
Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening;
-
Subjects who are negative for drugs of abuse and alcohol tests at screening and each admission;
-
Subjects who are non-smokers or who have not smoked or used nicotine-containing products for at least 3 months prior to screening;
-
Subjects with an estimated creatinine clearance ≥100 mL/minute for male subjects or
≥90 mL/minute for female subjects (Cockcroft-Gault method) at screening;
- Subjects who are able and willing to give written informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Quintiles Drug Research Unit at Guy's Hospital | London | United Kingdom |
Sponsors and Collaborators
- Gedeon Richter Plc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RGH-917-001