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

G

Gedeon Richter

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers;
Obese, Otherwise Healthy Volunteers

Treatments

Drug: Memantine
Drug: Placebo
Drug: Baclofen

Study type

Interventional

Funder types

Industry

Identifiers

NCT02001584
RGH-917-001

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

0 participants in 2 patient groups

Healthy Volunteers
Experimental group
Treatment:
Drug: Baclofen
Drug: Memantine
Obese, Otherwise Healthy Volunteers
Experimental group
Treatment:
Drug: Placebo
Drug: Baclofen
Drug: Memantine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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