PharmacokineticsPhase 1NCT00833391
Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)
A Phase 1 study testing open label in people with Pharmacokinetics and Healthy Volunteer, run by XenoPort, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the relative drug concentrations achieved with different formulations of GSK1838262 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Healthy Volunteer
- What is being tested?
- open label
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Mar 2009
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy, male and female subjects aged between 18 and 65 years old.
- normal body weight.
- normal ECG, vital signs and lab tests.
- normal kidney function
- agree to use acceptable contraceptive methods required.
- capable of giving written informed consent.
Who cannot join
- positive blood alcohol or urine drug test.
- positive hepatitis B/C and HIV
- donation of more than 450 mL blood within the 56 days.
- sensitivity to gabapentin
- pregnant or lactating females
- smoker
- certain medical conditions including heart disease, psychiatric disease, gastrointestinal disease, kidney or liver dysfunction
- history of seizure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Single Dose, Five-period Crossover Study to Evaluate the Relative Bioavailability of Different Formulations of GSK1838262 in Healthy Volunteers.
The purpose of this study is to evaluate the relative drug concentrations achieved with different formulations of GSK1838262 in healthy volunteers.
Read the detailed description
This is an open-label, randomized, single-dose, five-period, crossover study to evaluate the relative drug concentrations with different formulations of GSK1838262 in healthy volunteers. Four new formulations will be tested against the current formulation to identify the most promising new formulations for further development. Each subject will participate in five dosing periods and each period will be separated by at least seven days. Blood and urine samples will be collected over the 36 hour period following each dose administration to measure the drug concentrations.
- Conditions
- Pharmacokinetics, Healthy Volunteer
- Being tested
- open label
- Keywords
- healthy volunteer, formulations, bioavailability, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open labelDrug
This is an open-label, randomized, single-dose, five-period, crossover study. All subjects will receive GSK1838262.
| Study group | Role | What they receive |
|---|---|---|
| GSK1838262 arm | Experimental | Each subject will participate in five dosing sessions separated by at least seven days. Subjects will receive a single dose of current formulation of GSK1838262 or one of the four new formulations of GSK1838262 at each dosing session in random sequence. Receives: Drug: open label |
What is being measured
The primary outcome is the main question the study is designed to answer.
gabapentin concentrations in blood
Measured: measured up to 36 hr after dosing
Secondary outcomes (2)
gabapentin concentrations in urine
Measured: measured up to 36 hr after dosing
Safety and tolerability as measured by adverse events, vital signs, ECGs and clinical laboratory tests.
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- XenoPort, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833391
- Sponsor's protocol ID
- 110882
- Status last verified
- Mar 2010
- First submitted
- 29 Jan 2009
- Last updated
- 14 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single Dose, Five-period Crossover Study to Evaluate the Relative Bioavailability of Different Formulations of GSK1838262 in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT00833391
- Acronym / sponsor ID
- 110882
- Conditions
- Pharmacokinetics, Healthy Volunteer
- Keywords
- healthy volunteer, formulations, bioavailability, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- XenoPort, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 2 Feb 2009 (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 evaluate the relative drug concentrations achieved with different formulations of GSK1838262 in healthy volunteers.
Detailed description
This is an open-label, randomized, single-dose, five-period, crossover study to evaluate the relative drug concentrations with different formulations of GSK1838262 in healthy volunteers. Four new formulations will be tested against the current formulation to identify the most promising new formulations for further development. Each subject will participate in five dosing periods and each period will be separated by at least seven days. Blood and urine samples will be collected over the 36 hour period following each dose administration to measure the drug concentrations.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSK1838262 arm | Experimental | Drug: open labelEach subject will participate in five dosing sessions separated by at least seven days. Subjects will receive a single dose of current formulation of GSK1838262 or one of the four new formulations of GSK1838262 at each dosing session in random sequence. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- healthy, male and female subjects aged between 18 and 65 years old.
- normal body weight.
- normal ECG, vital signs and lab tests.
- normal kidney function
- agree to use acceptable contraceptive methods required.
Key exclusion criteria (8 listed)
- positive blood alcohol or urine drug test.
- positive hepatitis B/C and HIV
- donation of more than 450 mL blood within the 56 days.
- sensitivity to gabapentin
- pregnant or lactating females
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 |
|---|---|---|
| open labelThis is an open-label, randomized, single-dose, five-period, crossover study. All subjects will receive GSK1838262. | Drug | GSK1838262 arm |
Primary outcome
gabapentin concentrations in blood
Time frame: measured up to 36 hr after dosing
2 secondary outcomes
gabapentin concentrations in urine
Time frame: measured up to 36 hr after dosing
Safety and tolerability as measured by adverse events, vital signs, ECGs and clinical laboratory tests.
Time frame: throughout the study
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 14 May 2013.
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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 open label in people with Pharmacokinetics and Healthy Volunteer, run by XenoPort, Inc. at 1 site in United States.
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 6 inclusion and 8 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 14 May 2013. 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 States. 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?
gabapentin concentrations in blood (time frame: measured up to 36 hr after dosing). 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 14 May 2013.