A Study of TAK-375 in Healthy Adult Volunteers in a Sleep Lab Model of Transient Insomnia
Information source: Takeda Global Research & Development Center, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Transient Insomnia
Intervention: TAK-375 (Drug); TAK-375 (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Takeda Global Research & Development Center, Inc. Official(s) and/or principal investigator(s):
Stephen Sainati, MD, PhD, Study Director, Affiliation: Takeda Global Research & Development Center, Inc.
Summary
This was a safety and efficacy study of a single-dose of 8 mg and 16 mg TAK-375 compared to
placebo for one evening in subjects naïve to a sleep-laboratory environment.
Clinical Details
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Single-Dose Study of TAK-375 in Healthy Adult Volunteers in a Sleep Lab Model of Transient Insomnia
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Latency to persistent sleep as determined by one night PSG evaluation in a sleep lab.
Secondary outcome: Objective and subjective measures of efficacy.Sleep architecture variables. Residual pharmacological effects. Safety variables including adverse events, laboratory tests, vital signs, ECG results, and physical examination findings.
Detailed description:
Subjects meeting the initial Screening criteria checked in on the day of dosing. Subjects
were randomized to receive TAK-375 8 mg, 16 mg or placebo. Subjects received a
polysomnography (PSG) recording, then a single oral dose of study medication approximately 30
minutes prior to their habitual bedtime. Following lights out, PSG was performed
uninterrupted for 8 hours. After awakening the next day, a Visual Analog Scale (VAS) for Mood
and Feelings, Digit Symbol Substitution Test (DSST), Postsleep Questionnaire, and Memory
Recall tests were performed. Safety variables were also assessed. The subjects were
discharged after all safety and efficacy parameters were performed.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- All women were to have been nonpregnant and nonlactating.
- The subject's habitual bedtime was between 8: 30 PM and 12: 00 AM.
- The subject sleeps 6. 5 to 8 hours per night and had an sSL of less than or equal to 30
minutes.
Exclusion Criteria:
- The subject had any history of insomnia.
- The subject had spent 1 or more nights in a sleep laboratory.
- The subject had an Epworth Sleepiness Scale score of greater than 10.
- The subject had a known hypersensitivity to TAK-375 or related compounds, including
melatonin.
- The subject had previously participated in a study involving TAK-375.
- The subject had participated in any other investigational study or taken any
investigational drug within 30 days or 5 half lives prior to Day 1, whichever was
longer.
- The subject had sleep schedule changes required by employment (ie, shift work) within
3 months preceding Day 1 or had flown across greater than 3 time zones within 7 days
prior to Screening.
- The subject had participated in a weight loss program or substantially altered their
exercise routine within 30 days prior to Day 1.
- The subject had a history of seizures, sleep apnea, chronic obstructive pulmonary
disease, restless leg syndrome, schizophrenia, bipolar disorder, mental retardation,
or cognitive disorder.
- The subject had a history of a psychiatric disorder (including anxiety or depression)
within the past 12 months.
- The subject had any physical or psychiatric disorder that may be associated with sleep
disturbance.
- The subject used tobacco products during nightly awakenings.
- The subject had used melatonin or other drugs or supplements known to affect
sleep/wake function, or had consumed grapefruit or grapefruit juice within 5 days
prior to Day 1.
- The subject had used any CNS medication within 3 weeks (or 5 T1/2s of the drug,
whichever was longer) prior to Day 1. These medications were not to have been used to
treat psychiatric disorders.
Locations and Contacts
San Diego, California, United States
Palm Springs, California, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Atlanta, Georgia, United States
Overland Park, Kansas, United States
New York, New York, United States
Rochester, New York, United States
Cincinnati, Ohio, United States
Dublin, Ohio, United States
Columbia, South Carolina, United States
Houston, Texas, United States
Additional Information
Starting date: January 2003
Ending date: May 2003
Last updated: May 2, 2008
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