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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers;; Obese, Otherwise Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: Memantine; Drug: Baclofen

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Quintiles Drug Research Unit at Guy's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Volunteers	Drug: Memantine; Drug: Baclofen
Experimental: Obese, Otherwise Healthy Volunteers	Drug: Placebo; Drug: Memantine; Drug: Baclofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Gedeon Richter Plc.

Study record dates

Study Major Dates

• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: November 15, 2013
• First Submitted That Met QC Criteria: November 28, 2013
• First Posted (Estimate): December 5, 2013

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 4, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Dopamine Agents; GABA Agents; Neuromuscular Agents; Muscle Relaxants, Central; Antiparkinson Agents; Anti-Dyskinesia Agents; GABA Agonists; GABA-B Receptor Agonists; Memantine; Baclofen
• Other Study ID Numbers: RGH-917-001