Healthy Volunteers;Phase 1NCT02001584
A Study to Examine the, Safety, Tolerability and Pharmacokinetics Co-Administered Baclofen and Memantine in Obese and Lean, Otherwise Healthy Adults
A Phase 1 study testing Baclofen and Memantine in people with Healthy Volunteers; and Obese, Otherwise Healthy Volunteers, run by Gedeon Richter Plc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Healthy Volunteers;, Obese, Otherwise Healthy Volunteers
- What is being tested?
- Baclofen and Memantine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quintiles Drug Research Unit at Guy's Hospital
London
About this study
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.
- Being tested
- Baclofen, Memantine, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaclofenDrug
MemantineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Not described Receives: Drug: Baclofen; Drug: Memantine |
| Obese, Otherwise Healthy Volunteers | Experimental | Not described Receives: Drug: Baclofen; Drug: Memantine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of co-administered baclofen and memantine via C-SSRS
Measured: From Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via Adverse Events
Measured: From Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via Vital Signs
Measured: From Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via ECG
Measured: From Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via Clinical Laboratory Tests
Measured: From Baseline until Follow-up
Secondary outcomes (7)
Pharmacokinetic parameters of co-administered baclofen and memantine via Cmax
Measured: From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via Tmax
Measured: From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via AUC
Measured: From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via MRT
Measured: From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via CL/F
Measured: From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via T1/2
Measured: From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via CLR
Measured: From Baseline until Day 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers;Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
Sponsor and investigators
- Lead sponsor
- Gedeon Richter Plc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001584
- Sponsor's protocol ID
- RGH-917-001
- Status last verified
- Jul 2014
- First submitted
- 15 Nov 2013
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Examine the, Safety, Tolerability and Pharmacokinetics Co-Administered Baclofen and Memantine in Obese and Lean, Otherwise Healthy Adults
- ClinicalTrials.gov ID
- NCT02001584
- Acronym / sponsor ID
- RGH-917-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Gedeon Richter Plc.Industry (pharma, biotech, devices)
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 5 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Drug: Baclofen, Drug: Memantine |
| Obese, Otherwise Healthy Volunteers | Experimental | Drug: Baclofen, Drug: Memantine, Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baclofen | Drug | Healthy Volunteers, Obese, Otherwise Healthy Volunteers |
| Memantine | Drug | Healthy Volunteers, Obese, Otherwise Healthy Volunteers |
| Placebo | Drug | Obese, Otherwise Healthy Volunteers |
Primary outcome
Safety and tolerability of co-administered baclofen and memantine via C-SSRS
Time frame: From Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via Adverse Events
Time frame: From Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via Vital Signs
Time frame: From Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via ECG
Time frame: From Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via Clinical Laboratory Tests
Time frame: From Baseline until Follow-up
7 secondary outcomes
Pharmacokinetic parameters of co-administered baclofen and memantine via Cmax
Time frame: From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via Tmax
Time frame: From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via AUC
Time frame: From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via MRT
Time frame: From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via CL/F
Time frame: From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via T1/2
Time frame: From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via CLR
Time frame: From Baseline until Day 32
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Baclofen and Memantine in people with Healthy Volunteers; and Obese, Otherwise Healthy Volunteers, run by Gedeon Richter Plc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of co-administered baclofen and memantine via C-SSRS (time frame: From Baseline until Follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.