A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia (NCT04091438) | Clinical Trial Compass
CompletedPhase 1
A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
United States28 participantsStarted 2020-01-26
Plain-language summary
The purpose of this study is to evaluate the safety and tolerability of administering a single intravenous (IV) infusion dose of TAK-925 to adult participants with idiopathic hypersomnia (IH).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. A diagnosis of IH, as defined by the International Classification of Sleep Disorders-3 (ICSD-3) as verified by a previous nocturnal polysomnography (nPSG) and multiple sleep latency test (MSLT) study performed within the last 10 years.
✓. Onset of hypersomnia between 10 and 30 years of age.
✓. Seven consecutive days of actigraphy supported by a sleep diary obtained prior to the nPSG (Study Day -2) shows an average nightly sleep duration of greater than or equal to (\>=) 420 minutes during the participant's normal nocturnal sleep period.
✓. nPSG (Study Day -2) demonstrates that participant does not have other comorbid sleep disorders or clinically significant nocturnal hypoxemia (oxygen saturation ≤80% for ≥5% of total sleep time) and that their Apnea-Hypopnea Index (AHI) is less than or equal to (\<=) 10 per hour, their periodic limb movement arousal index (PLMAI) \<=15/hour, and that their total sleep time is \>=6.5 hours.
✓. Participants taking medication for treatment of excessive daytime sleepiness (EDS) must be willing to discontinue medication prior to randomization into the study.
✓. Body mass index (BMI) of 18 through 33 kilogram per square meter (kg/m\^2) inclusive.
✓. Epworth Sleepiness Scale (ESS) score \>=11 at screening and on Day -2.
✓. Blood pressure (BP) must be \<140 mmHg (systolic) and \<90 mmHg (diastolic) at screening and Study Day -2.
Exclusion criteria
✕. Average nightly sleep duration is \<=8 hours (480 minutes) and has insufficient sleep syndrome as evidenced by sleeping \>2 hours/night more on "off-days" relative to "work days" as determined by actigraphy and sleep diary obtained prior to the nPSG (Study Day -2).
What they're measuring
1
Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
Timeframe: Study Day 1 up to Study Day 11
2
Percentage of Participants With Markedly Abnormal Criteria for Clinical Safety Laboratory Tests
Timeframe: Study Day 1 up to Study Day 11
3
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements
Timeframe: From Predose up to Study Day 4
4
Percentage of Participants With Markedly Abnormal Criteria for 12-lead Safety Electrocardiogram (ECG) Parameters
✕. Positive urine screen for drugs of abuse and/or positive alcohol test at screening and Study Day -2.
✕. Resting heart rate (HR) outside of the range of 40 to 90 beats pper minute (bpm) off stimulants.
✕. Screening electrocardiogram (ECG) reveals a QT interval with Fridericia correction method \>450 ms (men) or \>470 ms (women).
✕. Usual bedtime later than 24:00 (midnight) or an occupation requiring nighttime shift work or variable shift work within the past 6 months, or travel with significant jet lag within 14 days before Study Day -2.
✕. History of a sleep disorder other than IH, based on interviews at the screening visit, such as obstructive sleep apnea (OSA), restless legs syndrome, or periodic limb movements of sleep (PLMS) associated with arousals.
✕. Use of any over-the-counter (OTC) or prescription medications with stimulating properties within 7 days prior to dosing or 5 half-lives (whichever is longer) that could affect the evaluation of EDS or use of sodium oxybate within 3 months of screening.
✕. Nicotine dependence that is likely to have an effect on sleep (e.g., a participant who routinely awakens at night to smoke) and/or an unwillingness to discontinue all smoking and nicotine use during the confinement portion of the study (Day -2 to Day 4).