None
Conditions
Interventions
Product Name: Eszopiclone
Product Code: GSK1755165
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: GSK1755165
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able and willing to provide written informed consent. 2. Aged 25 to 40 years (inclusive). 3. In good health as determined by medical and psychiatric history, physical examination, and serum chemistry, haematology, and urinalysis results Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Clinically significant psychiatric, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological (myasthenia gravis of particular concern), immunological, or haematological disease or abnormality, as determined by the study physician. 2) Pregnant or lactating females and females of child-bearing potential not using effective contraception. A female of childbearing potential must have a negative serum pregnancy test result at Visit 1 and must be using an acceptable method of birth control for a duration that is in accordance with the product label, or, for non-product methods, as determined by the investigator, prior to entry into the study and throughout the study. Methods that meet the GSK definition of highly effective (i.e. having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label) are: • Oral contraceptives, either combined or progestogen only; injectable progestogen; implants of levonorgestrel; estrogenic vaginal ring; or percutaneous contraceptive patches. • Intrauterine Device (IUD) or intrauterine system (IUS) that meets the above definition of effectiveness as stated in the product label. • Male partner who is sterile (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study and is the sole sexual partner for that female subject. For this definition, “documentation” refers to the outcome of the investigator's/designee’s verbal interview with the subject. • Double-barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository). 3) Symptoms/signs that are consistent with any sleep disorder, or a significant sleep irregularity as determined by the investigator and/or as detected during the screening PSG recording (Visit 2) e.g. apnoea-hypopnoea index of 10 or more per hour of sleep or Periodic Limb Movement with arousal of 10 or more per hour of sleep. 4) Sleep/wake cycle (e.g. due to shift work, abnormal sleep timing or duration) as assessed via clinical history and actigraphy, that is liable to prejudice the outcome of the study. 5) History of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence (with the exception of tobacco use) within the 12 months preceding Visit 1. 6) Smokes more than 5 cigarettes per day on average over the 1 month preceding Visit 1. [Please view protocol for further information]. 7) Positive urine drug screen (i.e., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates). A repeat test will not be allowed [Please view protocol for further information]. 8) Use of any psychotropic medications such as benzodiazepines, barbiturates and narcotics, or other medications, including over the counter (OTC) and herbal products that may affect sleep/wake function, within the 3 months preceding Visit 1, or a need to use any of these medications during the study. [Please view protocol for further information] 9) Positive alcohol breath test. A repeat test will not be allowed. [Please view protocol for further information]. 10) Females who consume more than 2 units of alcohol per day, or males who consume more than 3 units of alcohol per day, on average over the 1 month preceding Visit 1.please view protocol for further information. 11) Consumption of beverages containing a total 300 mg or more per day on average of caffeine or other xanthines (e.g.,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the existence and time course of potential next-day residual psychomotor effects of a single evening dose of 3mg eszopiclone, 7.5mg zopiclone, and placebo as measured by the mean tracking error of the Continuous Tracking Test (CTT).;Secondary Objective: • To evaluate the next day effects of a single evening dose of 3mg eszopiclone, 7.5mg zopiclone, and placebo on psychomotor performance, memory, and attention as measured using the CTT, Digit Symbol Substitution Test (DSST), N-Back tasks, and Critical Flicker Fusion (CFF). • To evaluate the next day effects of a single evening dose of 3mg eszopiclone, 7.5mg zopiclone, and placebo on subject-reported sedation, mood, and coordination as measured using Linear Analogue Rating Scales (LARS). • To evaluate the overall safety and tolerability of a single evening dose of 3mg eszopiclone, 7.5mg zopiclone, and placebo. ;Primary end point(s): Mean Tracking Error assessed during the CTT. The primary analysis will be performed on the mean of the 5 assessments conducted 7.5, 8, 8.5, 9 and 9.5 hours post dose (double blind). | — |
Countries
United Kingdom
Outcome results
None listed