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OpenTrials
Completed

NCT Number: NCT02001584

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quintiles Drug Research Unit at Guy's Hospital

London, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Baclofen

Drug

Memantine

Drug

Placebo

Drug

Primary outcomes

  1. Safety and tolerability of co-administered baclofen and memantine via C-SSRS

    Time frame: From Baseline until Follow-up

  2. Safety and tolerability of co-administered baclofen and memantine via Adverse Events

    Time frame: From Baseline until Follow-up

  3. Safety and tolerability of co-administered baclofen and memantine via Vital Signs

    Time frame: From Baseline until Follow-up

  4. Safety and tolerability of co-administered baclofen and memantine via ECG

    Time frame: From Baseline until Follow-up

  5. Safety and tolerability of co-administered baclofen and memantine via Clinical Laboratory Tests

    Time frame: From Baseline until Follow-up

Secondary outcomes

  1. Pharmacokinetic parameters of co-administered baclofen and memantine via Cmax

    Time frame: From Baseline until Day 32

  2. Pharmacokinetic parameters of co-administered baclofen and memantine via Tmax

    Time frame: From Baseline until Day 32

  3. Pharmacokinetic parameters of co-administered baclofen and memantine via AUC

    Time frame: From Baseline until Day 32

  4. Pharmacokinetic parameters of co-administered baclofen and memantine via MRT

    Time frame: From Baseline until Day 32

  5. Pharmacokinetic parameters of co-administered baclofen and memantine via CL/F

    Time frame: From Baseline until Day 32

  6. Pharmacokinetic parameters of co-administered baclofen and memantine via T1/2

    Time frame: From Baseline until Day 32

  7. Pharmacokinetic parameters of co-administered baclofen and memantine via CLR

    Time frame: From Baseline until Day 32

Sponsors and collaborators

Lead sponsor

Gedeon Richter Plc.

Industry

Registry information

Important dates

Primary completion
2014
Study completion
2014
First posted
Dec 5, 2013
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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