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NCT01332513 · ClinicalTrials.gov registry record · Phase 1
An Open Label, Randomised, Repeat Dose Study to Assess the Pharmacokinetic Performance of Five Ezogabine/Retigabine Modified Release (MR) Formulations at Steady State Compared to the Immediate Release (IR) Formulation.
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01332513 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 36 participants.
The verdict
NCT01332513, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This is an open-label, single centre, repeat dose, up- titration study in healthy male and female subjects to assess the pharmacokinetic (PK) performance of five prototypes of ezogabine modified release tablet formulations. The study will consist of a screening period, a treatment phase (consisting of a titration phase, bioavailability phase and food effect phase) and a post-treatment follow-up visit. The study duration from screening to follow up will be approximately 7 weeks. No study procedures will start before informed consent is obtained. Subjects will remain in the clinical unit for the duration of the treatment period (35 days). Subjects will receive repeat doses of ezogabine for up to 34 days starting at a dose of 100 mg IR TID (300mg TDD) with a standard meal (to be consumed 30 min prior to dosing) for Days 1-3, on days 4-6 subjects will receive 150mg IR TID (450mg TDD). On Day 7 through to the end of the study subjects will receive ezogabine (Mr or IR) at a dose of 600mgTDD. On Day 7 subjects will enter into a 6-way cross over period to investigate the 5 MR formulations being tested (each at 300mg BID) and the single IR formulation (at 200mg TID). Subjects will receive each formulaition for 4 days and blood samples for pharmacokinetic analysis will be collected up to 24 hours post dose on each 4th day (PK days). On Day 31 subjects will enter into a food effect phase to investigate the 5 MR formulations being tested (each at 600mg QD). Subjects in this period will have a PK day on Day 33 (following a standard breakfast), and on Day 34 (following a high fat breakfast) to investigate a food effect on the PK profile of ezogabine.
Interventions
- DRUG Investigational Medicinal Product (MR1)
- DRUG Investigational Medicinal Product (MR2)
- DRUG Investigational Medicinal Product (MR3)
- DRUG Investigational Medicinal Product (MR4)
- DRUG Investigational Medicinal Product (MR5)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2011-02-10 |
| Est. Completion | 2011-05-23 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01332513
The ClinicalTrials.gov registry entry for NCT01332513 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Investigational Medicinal Product (MR1) is the first listed.
NCT01332513 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01332513 about?
NCT01332513 is a clinical study titled "An Open Label, Randomised, Repeat Dose Study to Assess the Pharmacokinetic Performance of Five Ezogabine/Retigabine Modified Release (MR) Formulations at Steady State Compared to the Immediate Release (IR) Formulation.". This is an open-label, single centre, repeat dose, up- titration study in healthy male and female subjects to assess the pharmacokinetic (PK) performance of five prototypes of ezogabine modified release tablet formulations. The study will consist of a screening period, a treatment phase (consisting...
What is the current status of trial NCT01332513?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2011-02-10. Estimated completion is 2011-05-23.
What interventions are being tested in trial NCT01332513?
The interventions under investigation include: Investigational Medicinal Product (MR1) (DRUG), Investigational Medicinal Product (MR2) (DRUG), Investigational Medicinal Product (MR3) (DRUG), Investigational Medicinal Product (MR4) (DRUG), Investigational Medicinal Product (MR5) (DRUG).
Who is sponsoring clinical trial NCT01332513?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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