A Study to Examine the, Safety, Tolerability and Pharmacokinetics Co-Administered Baclofen and Memantine in Obese and Lean, Otherwise Healthy Adults

Study Overview
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Brief Summary
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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.

Conditions
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Healthy Volunteers;, Obese, Otherwise Healthy Volunteers

Intervention / Treatment
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* Drug: Baclofen
* Drug: Memantine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Volunteers<br> | Drug: Baclofen<br> <br> Drug: Memantine<br> <br> |
| Experimental: Obese, Otherwise Healthy Volunteers<br> | Drug: Baclofen<br> <br> Drug: Memantine<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |