Skip to content

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02001584
Enrollment
Unknown
Registered
2013-12-05
Start date
Unknown
Completion date
2014-05-31
Last updated
2014-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers;, Obese, Otherwise Healthy Volunteers

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.

Interventions

DRUGBaclofen
DRUGMemantine
DRUGPlacebo

Sponsors

Gedeon Richter Plc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years

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.

Design outcomes

Primary

MeasureTime frame
Safety and tolerability of co-administered baclofen and memantine via C-SSRSFrom Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via Adverse EventsFrom Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via Vital SignsFrom Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via ECGFrom Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via Clinical Laboratory TestsFrom Baseline until Follow-up

Secondary

MeasureTime frame
Pharmacokinetic parameters of co-administered baclofen and memantine via TmaxFrom Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via T1/2From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via CLRFrom Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via AUCFrom Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via MRTFrom Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via CL/FFrom Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via CmaxFrom Baseline until Day 32

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026