Epilepsy, PartialPhase 1NCT01691872
Pharmacokinetic Study of Retigabine Extended Release (XR) Formulation in Healthy Adult Japanese and Caucasian Subjects
A Phase 1 study testing Retigabine in people with Epilepsy, Partial, run by GlaxoSmithKline at 1 site in Japan.
Trial summary
This is an open-label, single centre, parallel group study to evaluate the safety and pharmacokinetics of single oral doses of retigabine XR formulation in healthy adult Japanese subjects. To compare the pharmacokinetic and safety profile, Caucasian subjects are also incorporated. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Partial
- What is being tested?
- Retigabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteJapan
- Study dates
- 10 Oct 2012to 18 Oct 2012
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subject between 20 and 45 years of age inclusive, at the time of signing the informed consent.
- Japanese ancestry defined as being born in Japan, having four ethnic Japanese grandparents, holding a Japanese passport or identity papers and being able to speak Japanese. OR Caucasian defined as an individual having four grandparents who are all descendents of the original people of Europe.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight ≥ 50 kg and BMI within the range 18.5 - 24.9 kg/m2 (inclusive).
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed separately. This criterion must be followed from the time of the first dose of study medication until 1 week post-last dose
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Single QTcB or QTcF< 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
Who cannot join
- Subject has made a suicide attempt in the past or, in the investigator's judgment, poses a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behavior in the past 6 months and/or any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
- A positive pre-study Hepatitis B surface antigen, Hepatitis C antibody or HIV antigen/antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 360 ml of beer, 150 ml of table wine or 45 ml of 80 proof distilled spirits.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Show all 15Show fewer
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single Centre, Parallel Group Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of Retigabine Extended Release (XR) Formulation in Healthy Adult Japanese and Caucasian Subjects
This is an open-label, single centre, parallel group study to evaluate the safety and pharmacokinetics of single oral doses of retigabine XR formulation in healthy adult Japanese subjects. To compare the pharmacokinetic and safety profile, Caucasian subjects are also incorporated. This study is intended to facilitate inclusion of Japanese patients in the global phase III program for retigabine XR formulation.
- Conditions
- Epilepsy, Partial
- Being tested
- Retigabine
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetigabineDrug
Retigabine
| Study group | Role | What they receive |
|---|---|---|
| Japanese | Experimental | Retigabine 300mg single-dose Receives: Drug: Retigabine |
| Caucasian | Experimental | Retigabine 300mg single-dose Receives: Drug: Retigabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞ of retigabine
Area under the concentration-time curve from pre-dose to last time of quantifiable concentration of retigabine
Measured: up to 96h post dose
Cmax of retigabine
Maximum observed concentration of retigabine
Measured: up to 96h post dose
Tmax of retigabine
Time of occurance of Cmax of retigabine
Measured: up to 96h post dose
t1/2 of retigabine
Terminal phase half-life of retigabine
Measured: up to 96h post dose
Adverse Events
Number of participants with adverse events as a measure of safety and tolerability (evaluated by the result of Clinical safety laboratory tests, vital signs, 12-lead ECG, telemetry and clinical monitoring/observation
Measured: up to 96h post dose
Secondary outcomes (6)
AUC0-∞ of NAMR
Area under the concentration-time curve from pre-dose to last time of quantifiable concentration of NAMR
Measured: up to 96h post dose
Cmax of NAMR
Maximum observed concentration of NAMR
Measured: up to 96h post dose
Tmax of NAMR
Time of occurance of Cmax of NAMR
Measured: up to 96h post dose
t1/2 of NAMR
Terminal phase half-life of NAMR
Measured: up to 96h post dose
fe
Percent of retigabine and NAMR excreted in urine
Measured: up to 96h post dose
CLr
Renal clearance of retigabine and NAMR
Measured: up to 96h post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study start10 Oct 2012
- Primary completion18 Oct 2012
- Study completion18 Oct 2012
Why it stopped: Development plan of retigabine XR in Japan was readjusted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, PartialStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691872
- Sponsor's protocol ID
- 116247
- Status last verified
- Sep 2018
- First submitted
- 13 Sep 2012
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Centre, Parallel Group Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of Retigabine Extended Release (XR) Formulation in Healthy Adult Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT01691872
- Acronym / sponsor ID
- 116247
- Conditions
- Epilepsy, Partial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Development plan of retigabine XR in Japan was readjusted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2012 (actual)
- Primary completion
- 18 Oct 2012 (actual)
- Study completion
- 18 Oct 2012 (actual)
- First posted
- 25 Sep 2012 (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.
This is an open-label, single centre, parallel group study to evaluate the safety and pharmacokinetics of single oral doses of retigabine XR formulation in healthy adult Japanese subjects. To compare the pharmacokinetic and safety profile, Caucasian subjects are also incorporated. This study is intended to facilitate inclusion of Japanese patients in the global phase III program for retigabine XR formulation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Japanese | Experimental | Drug: RetigabineRetigabine 300mg single-dose |
| Caucasian | Experimental | Drug: RetigabineRetigabine 300mg single-dose |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male subject between 20 and 45 years of age inclusive, at the time of signing the informed consent.
- Japanese ancestry defined as being born in Japan, having four ethnic Japanese grandparents, holding a Japanese passport or identity papers and being able to speak Japanese. OR Caucasian defined as an individual having four grandparents who are all descendents of the original people of Europe.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight ≥ 50 kg and BMI within the range 18.5 - 24.9 kg/m2 (inclusive).
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed separately. This criterion must be followed from the time of the first dose of study medication until 1 week post-last dose
Key exclusion criteria (15 listed)
- Subject has made a suicide attempt in the past or, in the investigator's judgment, poses a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behavior in the past 6 months and/or any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
- A positive pre-study Hepatitis B surface antigen, Hepatitis C antibody or HIV antigen/antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 360 ml of beer, 150 ml of table wine or 45 ml of 80 proof distilled spirits.
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 |
|---|---|---|
| RetigabineRetigabine | Drug | Caucasian, Japanese |
Primary outcome
AUC0-∞ of retigabine
Time frame: up to 96h post dose
Area under the concentration-time curve from pre-dose to last time of quantifiable concentration of retigabine
Cmax of retigabine
Time frame: up to 96h post dose
Maximum observed concentration of retigabine
Tmax of retigabine
Time frame: up to 96h post dose
Time of occurance of Cmax of retigabine
t1/2 of retigabine
Time frame: up to 96h post dose
Terminal phase half-life of retigabine
Adverse Events
Time frame: up to 96h post dose
Number of participants with adverse events as a measure of safety and tolerability (evaluated by the result of Clinical safety laboratory tests, vital signs, 12-lead ECG, telemetry and clinical monitoring/observation
6 secondary outcomes
AUC0-∞ of NAMR
Time frame: up to 96h post dose
Cmax of NAMR
Time frame: up to 96h post dose
Tmax of NAMR
Time frame: up to 96h post dose
t1/2 of NAMR
Time frame: up to 96h post dose
fe
Time frame: up to 96h post dose
CLr
Time frame: up to 96h post dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Retigabine in people with Epilepsy, Partial, run by GlaxoSmithKline at 1 site in Japan.
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 8 inclusion and 15 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: withdrawn, as of the sponsor's last update on 17 Sep 2018. 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 Japan. 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 was withdrawn before enrolling participants, so there are no results.
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?
AUC0-∞ of retigabine (time frame: up to 96h post dose). 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 17 Sep 2018.