This was a safety study of 16 mg of TAK-375 and a placebo taken once daily for two days in
subjects with sleep apnea.
Inclusion Criteria:
- The subject was male or female, 21 to 64 years of age, inclusive.
- Females of childbearing potential were nonpregnant and nonlactating and used
appropriate birth control for the study duration.
- The subject had a diagnosis of mild (AHI of ≥5 and <10) to moderate (AHI of ≥10 and
≤20) obstructive or mixed sleep apnea.
- The subject's habitual bedtime was between 8: 30 PM and 12: 00 AM.
- The subject reported sleeping more than 4 hours per night.
- The subject had an AHI (per hour of sleep) greater than or equal to 5, as determined
by PSG during the PSG Screening night.
Exclusion Criteria:
- 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 and/or taken any
investigational drug within 30 days or 5 half lives prior to the first dose of study
medication, whichever was longer.
- The subject had an AHI (per hour of sleep) greater than 20, as determined by PSG
during the PSG Screening night.
- The subject had a history of surgical intervention for sleep apnea and/or had used a
Continuous Positive Airway Pressure device or a dental device within 30 days of office
Screening.
- The subject had SaO2 less than 80% at any time during the PSG Screening night.
- The subject had periodic leg movement with arousal index (per hour of sleep) of
greater than 20 during the PSG Screening night.
- The subject had an acute, clinically significant illness within 2 weeks or had been
hospitalized within 4 weeks of study participation.
- The subject had sleep schedule changes required by employment (ie, shift work) within
3 months prior to the first dose of study medication or had flown across more than 3
time zones within 7 days prior to Initial Screening.
- The subject had a history of seizures, chronic obstructive pulmonary disease, restless
leg syndrome, other known sleep disorders, period limb movement disorder,
schizophrenia, bipolar disease, mental retardation, or a cognitive disorder.
- The subject had a history of a psychiatric disorder (including anxiety or depression)
within the past 12 months.
- The subject was unable to discontinue the use of hypnotics (other than study drug) for
the study duration.
- The subject used melatonin, other drugs, or supplements known to affect sleepwake
function within 1 week or 5 half lives prior to the first dose of study medication,
whichever was longer.
- The subject used any central nervous system medications within 1 week or 5 half lives
prior to the first dose of study medication, whichever was longer. These medications
could not have been used to treat psychiatric disorders.
- The subject intended to continue to use any disallowed prescription or
over-the-counter (OTC) medication that is known to affect the sleep-wake function or
otherwise interfere with evaluation of study medication. The subject reported all
prescription and OTC medications taken 3 weeks prior to Screening.
- The subject had any condition(s) that would, in the investigator's opinion, affect
sleep-wake function or prohibit the subject from completing the study, or where study
participation would not be in the best interest of the subject.
- Subject had a history of drug addiction or drug abuse within the past 12 months.
