Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet

Condition(s) targeted: Insomnia

Intervention: Zopiclone (Drug); Zolpidem (Drug); Placebo (sublingual tablet) (Drug); Placebo (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Transcept Pharmaceuticals

Official(s) and/or principal investigator(s):
Annemiek Vermeeren, PhD, Principal Investigator, Affiliation: Maastricht University

Overall contact:
Transcept Pharmaceuticals, Phone: 510-215-3567

A study in healthy volunteers of the next morning driving performance after middle-of-the-night dosing of 3. 5 mg zolpidem tartrate sublingual tablet, a sleep aid. The next morning driving performance will be measured by taking a standardized driving test.

Official title: Assessment of Next-Morning Driving Performance After Middle of the Night Administration of Zolpidem Tartrate Sublingual Tablet 3.5 mg in Healthy Adult Volunteers: Single-center, Double-blind, Randomized, Placebo-controlled, Four-way Crossover Study

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Assessment of impaired driving as determined by the number of subjects whose Standard Deviation of Lateral Position (a common measure of onroad weaving) on active drug exceeds 2.5 cm versus placebo

Secondary outcome:

Assessment of impaired driving as determined by the number of subjects whose Standard Deviation of Lateral Position (a common measure of onroad weaving) on active drug exceeds 2.0 cm versus placebo

Assessment of impaired driving as determined by the number of subjects whose Standard Deviation of Lateral Position (a common measure of onroad weaving) on active drug exceeds 3.5 cm versus placebo

Active versus placebo (mean ±) standard deviation of Standard Deviation of Lateral Position (a common measure of on-road weaving)

Active versus placebo (mean ±) standard deviation of Standard of Deviation of Speed (a common measure of the ability to maintain a constant driving speed)

Minimum age: 21 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female subjects between the ages of 21 and 64 inclusive. For female subjects

only: Female subjects will be included if they are post-menopausal or sterilized, or if they are of childbearing potential, they are not breastfeeding, their pregnancy test is negative, they have no intention of becoming pregnant during the course of the study, and are using adequate contraceptive drugs or devices. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization or abstinence. Females using oral contraception must have started using the medication at least 4 weeks prior to screening. Surgical sterilization must have occurred at least 6 weeks prior to screening.

- Good health on the basis of pre-study history and physical examination, vital signs

and the results of blood chemistry, hematology, and urinalysis

- Good binocular visual acuity, corrected or uncorrected

- Possession of valid driver's license for 3 years or more

- Driving experience at least 3000 km/year

- Signed informed consent

Exclusion Criteria:

- A history of drug addiction or drug or substance abuse, including alcohol abuse,

within the past 12 months

- Has a history of restless legs syndrome, sleep apnea, narcolepsy or other primary

sleep disorder

- A known hypersensitivity to zolpidem or zopiclone

- Has undergone oral surgery, tooth extraction or piercing of the lip/tongue within 60

days prior to screening

- Has used any medication to promote sleep, including herbal medications, within 14

days (or 5 half-lives of the drug, whichever is longer) prior to screening

- Prescription medications for other health conditions are allowed as long as the

subject has been on a stable dose at least 30 days prior to screening

- Has taken any drugs known to induce hepatic drug metabolism (i. e., rifampin) within

30 days prior to screening

- BMI > 29 Kg/M^2

- Current use of medication that affects driving performance

- Smokes more than 10 cigarettes/day

- Uses tobacco products during periods of nighttime awakening

- Consumes more than 6 cups of coffee/day

- Consumes more than 21 glasses of alcohol/week

- Has received an investigational drug within 60 days or 5 half-lives (whichever is

longer) prior to screening

- Has any additional condition(s) that in the Investigator's opinion would:

- Affect sleep/wake function

- Prohibit the subject from completing the study

- Not be in the best interest of the subject to participate in the study

Transcept Pharmaceuticals, Phone: 510-215-3567

Maastricht University, Maastricht 6229 ER, Netherlands; Recruiting

Starting date: June 2010
Last updated: July 1, 2010