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

NCT02001584 | Completed Phase 1

• 1 other identifier: RGH-917-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers;; Obese, Otherwise Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• 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

Study Arms (2)

Healthy Volunteers

EXPERIMENTAL

Drug: Baclofen; Drug: Memantine

Obese, Otherwise Healthy Volunteers

EXPERIMENTAL

Drug: Baclofen; Drug: Memantine; Drug: Placebo

Interventions

Baclofen DRUG

Healthy Volunteers; Obese, Otherwise Healthy Volunteers

Memantine DRUG

Healthy Volunteers; Obese, Otherwise Healthy Volunteers

Placebo DRUG

Obese, Otherwise Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Gedeon Richter Plc.: lead

Study Sites (1)

Quintiles Drug Research Unit at Guy's Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Interventions

Baclofen; Memantine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: December 5, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 8, 2014

Record last verified: 2014-07

Locations

GB (1)