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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental |
| |
| Obese, Otherwise Healthy Volunteers | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baclofen | Drug |
| ||
| Memantine |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quintiles Drug Research Unit at Guy's Hospital | London | United Kingdom |
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| Drug |
|
| Placebo | Drug |
|
| 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 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001418 | Baclofen |
| D008559 | Memantine |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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