NCT01516372

A Study to Evaluate the Effect of Gabapentin on Cardiac Repolarization in Healthy Volunteers

A Randomized, Double-blind, Single Dose Crossover Study to Assess the Effect of Gabapentin Enacarbil on Cardiac Conduction as Compared With Placebo and Moxifloxacin in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: XenoPort, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This will be a randomized, double-blind, placebo- controlled cross-over study to investigate the effect of GEn on cardiac repolarisation parameters compared with placebo and a positive control, moxifloxacin. Approximately 52 subjects will be recruited to the study and will take part in four dosing sessions. Subjects will receive, in a randomized order, a single dose of 1200 mg GEn, 6000 mg GEn (supratherapeutic dose), 400 mg moxifloxacin (positive control) and placebo. Twelve lead continuous ECG monitoring will be conducted from pre-dose to approximately 24 hours after dosing on Day 1 of each study session. The primary comparison of interest will be the mean change from baseline in the time-matched differences in QTcF between each GEn treatment and placebo.

Detailed description

This is a 4-period, randomized, active-and placebo-controlled, double-dummy, double-blind cross-over study to evaluate the effect of single doses of GEn on cardiac conduction parameters in healthy subjects. Screening will occur within approximately 28 days of the first scheduled dose of study medication. Each subject will participate in 4 dosing sessions at least one week apart. Prior to dosing in each period, the investigator will review the scheduled assessments to confirm the subject's suitability for the study including review of study entry criteria and lifestyle restrictions. All subjects will receive single doses of GEn 1200 mg, GEn 6000 mg, moxifloxacin 400 mg and placebo in a randomized sequence. Dosing with moxifloxacin will be in the fasted state and GEn will be administered following a standard meal. A double dummy approach will be used to maintain blinding. Thus, on each dosing day, moxifloxacin or moxifloxacin placebo will be administered in the fasted state in the morning and GEn or matched placebo will be administered 2 hours later after a standard meal. During each treatment period, subjects will report to the clinical research unit the day before dosing (Day 1) and will remain until completion of the last assessment on Day 2. Twelve-lead ECGs including continuous Holter monitoring, clinical laboratory safety tests, vital sign measurements, physical examinations, adverse event reports, and pharmacokinetic samples will be collected throughout the study. In each study period, cardiac conduction will be measured using a 24-hour continuous 12-lead Holter monitor from the morning of Day 1 until the morning of Day 2. Extraction of the Holter monitor data in triplicate for analysis will begin on Day 1 at timepoints indicated in the Time and Events Table (Section 4.7). These timepoints were selected to cover the Cmax of both moxifloxacin and GEn. If no clinically significant abnormalities are noted, subjects will be discharged from the clinical research unit after the completion of all assessments on Day 2 in each period. A minimum 7-day washout period will separate each treatment period. A follow-up visit will be conducted approximately 7 to 14 days after administration of the last dose of study medication in treatment period 4

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	GEn 1200mg	1200 mg of Gen administered as a single dose
DRUG	Gen 6000 mg	6000 mg of Gen administered as a single dose
DRUG	GEn Placebo	Placebo to match GEn Tablets
DRUG	Moxifloxacin Placebo	Placebo to match Moxifloxacin
DRUG	Moxifloxacin	400 mg Moxifloxacin administered as a single dose

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2012-01-24
• Last updated: 2021-04-12

Locations

1 site across 1 country: United States