A Study to Evaluate the Effect of Gabapentin on Cardiac Repolarization in Healthy Volunteers
Condition: Restless Legs Syndrome
MeSH terms: Restless Legs Syndrome
Study type: Interventional
Phase: Phase 1

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
    

Intervention name(s): GEn 1200mg; Gen 6000 mg; GEn Placebo; Moxifloxacin Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1200 mg of Gen administered as a single dose; 6000 mg of Gen administered as a single dose; Placebo to match GEn Tablets; Placebo to match Moxifloxacin; 400 mg Moxifloxacin administered as a single dose
Other intervention name(s): gen1200; gen6000; moxifloxacin 400
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: GEn, moxifloxacin, cardiac repolarisation, QT/QTc