Efficacy of Ramelteon on Transient Insomnia in Healthy Adults

• Status: Completed
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), in healthy subjects within a sleep lab.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Takeda

Criteria

Inclusion Criteria

• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

• Habitual bedtime is between 8:30 p.m. and 12:00 a.m.

• Sleeps 6.5 to 8 hours per night and has a subjective sleep latency of less than or equal to 30 minutes.

• Body mass index between 18 and 34, inclusive.

Exclusion Criteria:

• Any history of insomnia.

• Spent one or more nights in a sleep laboratory.

• Epworth Sleepiness Scale score of greater than 10.

• Known hypersensitivity to Ramelteon or related compounds, including melatonin.

• Previously participated in a study involving Ramelteon.

• Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to Day 1, whichever is longer.

• Sleep schedule changes required by employment (ie, shift work) within three months preceding Day 1 or has flown across greater than three time zones within seven days prior to screening.

• Participated in a weight loss program or substantially altered their exercise routine within 30 days prior to Day 1.

• History of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.

• History of a psychiatric disorder (including anxiety or depression) within the past 12 months.

• History of drug addiction or drug abuse within the past 12 months.

• Any physical or psychiatric disorder that may be associated with sleep disturbance.

• History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised and/or regularly consumes 4 or more alcoholic drinks per day.

• Current significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic or metabolic disease.

• Uses tobacco products during nightly awakenings.

• Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.

• Positive hepatitis panel.

• Positive urine drug screen including alcohol at screening or a positive breathalyzer test at check-in.

• 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.

• Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:

• Anxiolytics

• Hypnotics

• Antidepressants

• Anticonvulsants

• Sedating H1 antihistamines

• Systemic steroids

• Respiratory stimulants (eg, theophylline)

• Decongestants

• Over-the-counter and prescription stimulants

• Over-the-counter and prescription diet aids

• Central nervous system active drugs

• Narcotic analgesics

• All beta blockers

• St. John's Wort

• Kava-kava

• gingko biloba