Idiopathic Hypersomnia
Conditions
Interventions
investigational material(s)
Generic name etc : TAK-925 Dose A + Placebo
INN of investigational material : -
Therapeutic category code : 117 Psychotropic agents
Dosage and Administration for Investigat
Sponsors
Takeda Pharmaceutical Company Limited
Millennium Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.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. 2.Onset of hypersomnia between 10 and 30 years of age. 3.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. 4.nPSG (Study Day-2) demonstrates that participant does not have other comorbid sleep disorders or clinically significant nocturnal hypoxemia (oxygen saturation less than or equal to (=5% of total sleep time) and that their Apnea-Hypopnea Index (AHI) is less than or equal to (=6.5 hours. 5.Participants taking medication for treatment of excessive daytime sleepiness (EDS) must be willing to discontinue medication prior to randomization into the study. 6.Body mass index (BMI) of 18 through 33 kg/m^2 inclusive. 7.Epworth Sleepiness Scale (ESS) score >=11 at screening and on Day -2. 8.Blood pressure (BP) must be <140 mmHg (systolic) and <90 mmHg (diastolic) at screening and Study Day -2.
Exclusion criteria
Exclusion criteria: 1 .Average nightly sleep duration is 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). 2. Positive urine screen for drugs of abuse and/or positive alcohol test at screening and Study Day -2. 3. Resting heart rate (HR) outside of the range of 40 to 90 beats per minute (bpm) off stimulants. 4. Screening electrocardiogram (ECG) reveals a QT interval with Fridericia correction method >450 ms (men) or >470 ms (women). 5. 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. 6. 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. 7. 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. 8. 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).. 9. Caffeine consumption of more than 600 mg/day for 7 days before Study Day 1 (1 serving of coffee is approximately equivalent to 120 mg of caffeine) and/or unwilling to discontinue all caffeine during the confinement portion of the study (Day -2 to Day 4). 10. Alcohol use that is likely to have an effect on sleep and/or an unwillingness to discontinue all alcohol use from 72 hours before check-in through discharge on Study Day 4. 11. History of epilepsy or seizures, including having had a single seizure or a history of childhood febrile seizures or has a clinically significant history of head trauma. 12. Answered "YES" on Questions 4 or 5 on the Suicidal Ideation subscale of the Columbia Suicide Severity Rating Scale (C-SSRS) at screening (defined period as 3 months prior to screening) or evidence of suicidal behavior within 6 months of screening as measured by the Suicidal Behavior subscale of the C-SSRS. 13. Diagnosis of major depressive disorder (DSM-5), within the past 6 months or Beck Depression Inventory II (BDI-II) total score of >16 at the screening visit. 14. History of cerebral ischemia, transient ischemic attack, intracranial aneurysm, or arteriovenous malformation. 15. Known coronary artery disease, a history of myocardial infarction, angina, cardiac rhythm abnormality, or heart failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Percentage of Participants who Experience at Least One Treatment Emergent Adverse Event (TEAE) Time Frame: Study Day 1 up to Study Day 11 An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug. safety Percentage of Participants With Markedly Abnormal Criteria for Clinical Safety Laboratory Tests Time Frame: Study Day 1 up to Study Day 11 Clinical laboratory evaluations include hematology, blood chemistry, and urinalysis. safety Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements Time Frame: Study Day 1 up to Study Day 4 Vital signs include body temperature, respiratory rate, systolic and diastolic blood pressure and heart rate. safety Percentage of Participants With Markedly Abnormal Criteria for 12-Lead Safety Electrocardiogram (ECG) Parameters Time Frame: Study Day 1 up to Study Day 4 A standard 12-lead ECG will be performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics Ceoi: Observed Plasma Concentration at the end of Infusion for TAK-925 Time Frame: Treatment Periods 1 and 2: Study Day 1 pre-dose, at multiple time points (up to 9 hours) after start of infusion, and at multiple time points (up to 15 hours) after end of infusion pharmacokinetics AUCinf: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-925 Time Frame: Treatment Periods 1 and 2: Study Day 1 pre-dose, at multiple time points (up to 9 hours) after start of infusion, and at multiple time points (up to 15 hours) after end of infusion pharmacokinetics AUC Last: Area Under the Plasma Concentration-Time Curve from Time 0 to Time of the Last Quantifiable Concentration for TAK-925 Time Frame: Treatment Periods 1 and 2: Study Day 1 pre-dose, at multiple time points (up to 9 hours) after start of infusion, and at multiple time points (up to 15 hours) after end of infusion | — |
Countries
Japan, North America
Outcome results
None listed