- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01411124
Study to Assess the Effect of Gabapentin Enacarbil on Simulated Driving in Healthy Subjects
July 15, 2013 updated by: XenoPort, Inc.
A Randomized, Double-Blind, Active- and Placebo-Controlled, Crossover Study Assessing the Effect of 600 mg Gabapentin Enacarbil on Simulated Driving in Healthy Subjects
This is a double-blind, placebo-and active-controlled 3-period crossover study designed to assess the effect of GEn 600 mg on simulated driving performance in healthy volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
proportional systemic gabapentin exposure over a wide dose range.
This is a double-blind, placebo-and active-controlled 3-period crossover study designed to assess the effect of GEn 600 mg on simulated driving performance.
Subjects will receive each of 3 treatments in a randomized order: GEn 600 mg, placebo and placebo/diphenhydramine 50 mg.
Each treatment period will consist of 6 days, with subjects being dosed at approximately 5 pm on each dosing day.
The placebo /diphenhydramine treatment will consist of placebo on Days 1-4 and 6 and 50 mg diphenhydramine on Day 5. Placebo will be administered on Day 6 in all treatment periods to ensure washout of drug prior to the start of the next treatment period.
Simulated driving performance will be assessed at baseline (prior to randomization) and on Day 5 in the evening (7-9 pm) and on Day 6 between7-9 am and between 11am-1pm for each treatment period.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78744
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and 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
- Male or female between 18 and 65 years of age, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation at least 6 months previously or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/mL and estradiol < 40 pg/mL (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the follow-up visit is completed.
- Body weight > 50 kg and Body Mass Index (BMI) within the range 19 - 30 kg/m2 (inclusive)
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
- QTcB < 450 msec
- Creatinine clearance (CrCl) >80 mL/min. CrCl is estimated using the equation of Cockcroft and Gault. See study procedure manual for details on creatinine clearance calculations.
- AST, ALT, alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- Currently a licensed, experienced driver who drives at least 3 times a week for the past 3 years and with visual acuity assessed by the investigator as being adequate for driving
- Able to complete a 1 hour simulated driving test and demonstrate satisfactory driving skills at screening
Exclusion Criteria:
- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive test for HIV antibody
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 drinks/week for men or >7 drinks/week for women. One drink is equivalent to (12 g alcohol) = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (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).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- 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 gabapentin, DPH 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 a 56 day period
- Pregnant females as determined by positive serum human chorionic gonadotrophin (hCG) test at screening or prior to dosing
- Lactating females
- Unwillingness or inability to follow the procedures outlined in the protocol
- The subject has a screening heart rate <50 or >100 bpm or a systolic blood pressure >140 or <100 mmHg or a diastolic blood pressure >90 or <60 mmHg in the semi-supine position after at least 3 minutes of rest.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease
- History of seizures other than febrile seizures as a child
- Subjects who have received any medications known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration, in the opinion of the Sponsor or Investigator
- Subjects with a creatine kinase (CK) value of greater than the upper limit of normal that is not explainable by recent strenuous exercise and the value does not return within normal range upon retest
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Subject is mentally or legally incapacitated
- Subjects with a sleep disorder e.g. sleep apnea, narcolepsy or primary insomnia
- Shift workers who are not on normal day/night sleep cycles
- Subjects with a history of closed angle glaucoma, urinary retention or other conditions for which DPH is contra-indicated
- Has active suicidal plan/intent or has had active suicidal thoughts in the past 6 months. Has history of suicide attempt in the last 2 years or more than 1 lifetime suicide attempt
- Subjects who have consumed an average of > 5 cups of caffeinated beverages per day within 20 days of the screening visit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
placebo to match
|
placebo
|
Experimental: Gabapentin Enacarbil
600 mg of Gabapentin Enacarbil
|
placebo
600 mg investigational compound
Other Names:
|
Active Comparator: diphenhydramine
50 mg
|
placebo
50 mg active comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lane performance Variability
Time Frame: From Day-1 baseline to end of treatment. Participants will be followed for the duration of the clinic visit an average of 3 weeks.
|
change from baseline in lane position variability
|
From Day-1 baseline to end of treatment. Participants will be followed for the duration of the clinic visit an average of 3 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Speed Variability
Time Frame: from baseline to end of treatment Participants will be followed for the duration of the clinic visit an average of 3 weeks
|
Change from baseline in speed variability
|
from baseline to end of treatment Participants will be followed for the duration of the clinic visit an average of 3 weeks
|
number of simulated crashes
Time Frame: on Days 5 and 6. The subjects will be followed for the duration of the clinic visit an average of 3 week
|
number of simulated crashes
|
on Days 5 and 6. The subjects will be followed for the duration of the clinic visit an average of 3 week
|
Visual Analog Scale
Time Frame: Baseline to end of treatment. The subjects will be followed for the duration of the clinic visit an average of 3 weeks
|
Pre driving alterness measured by the Visual analog scale
|
Baseline to end of treatment. The subjects will be followed for the duration of the clinic visit an average of 3 weeks
|
Visual analog scale on post driving alertness
Time Frame: baseline to days 5 and 6. The subjects will be followed for the duration of the clinic visit an average of 3 weeks
|
Post driving alterness measured by visual alterness scale
|
baseline to days 5 and 6. The subjects will be followed for the duration of the clinic visit an average of 3 weeks
|
Visual Analog scale of the difference between pre and post driving alertness
Time Frame: baseline to days 5 and 6. The subjects will be followed for the duration of the clinic visit an average of 3 weeks
|
difference between pre and post driving alertness
|
baseline to days 5 and 6. The subjects will be followed for the duration of the clinic visit an average of 3 weeks
|
Incidents of Adverse events
Time Frame: baseline to end of study. The subjects will be followed for the duration of the clinic visit an average of 3 weeks
|
safety and tolerability from baseline to end of study
|
baseline to end of study. The subjects will be followed for the duration of the clinic visit an average of 3 weeks
|
Plasma concentrations of gabapentin
Time Frame: Day 5. The subjects will be followed for the duration of the clinic visit an average of 3 weeks
|
Plasma concentration of gabapentin on completion of driving test
|
Day 5. The subjects will be followed for the duration of the clinic visit an average of 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
July 28, 2011
First Submitted That Met QC Criteria
August 4, 2011
First Posted (Estimate)
August 8, 2011
Study Record Updates
Last Update Posted (Estimate)
July 16, 2013
Last Update Submitted That Met QC Criteria
July 15, 2013
Last Verified
November 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Dyskinesias
- Psychomotor Disorders
- Parasomnias
- Psychomotor Agitation
- Restless Legs Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Anti-Anxiety Agents
- Anticonvulsants
- Anesthetics, Local
- Antimanic Agents
- Anti-Allergic Agents
- Sleep Aids, Pharmaceutical
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Gabapentin
- Diphenhydramine
- Promethazine
Other Study ID Numbers
- 114111
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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