A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
- Registration Number
- NCT04091438
- Lead Sponsor
- Millennium Pharmaceuticals, Inc.
- Brief 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).
- Detailed Description
The drug being tested in this study in participants with IH is called TAK-925. The study will have 2-treatment crossover groups. The study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of a single intravenous (IV) dose of Dose A in participants with IH.
The study will enroll 40 patients. Participants will be randomly assigned to one of the two treatment sequence groups as indicated below:
* TAK-925 + Placebo
* Placebo + TAK-925
On Day 1 of each treatment period, TAK-925 or placebo will be administered as a single 9-hour IV infusion.
The multicenter study will be conducted in the United States and Japan. The overall duration of treatment in this study is approximately 41 days including screening up to 28 days, confinement for 6 days and end of study follow up telephone call on Study Day 11.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- 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.
- 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).
- 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).
- 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).
- 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.
- 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.
- 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.
- 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.
- History of cerebral ischemia, transient ischemic attack, intracranial aneurysm, or arteriovenous malformation.
- Known coronary artery disease, a history of myocardial infarction, angina, cardiac rhythm abnormality, or heart failure.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description TAK-925 Dose A + Placebo TAK-925 TAK-925 112 milligram (mg), 9-hour intravenous infusion once on Day 1, Treatment Period 1 followed by 24 hours wash-out period, followed by TAK-925 placebo-matching 9-hour intravenous infusion once on Day 3, Treatment Period 2. TAK-925 Dose A + Placebo TAK-925 Placebo TAK-925 112 milligram (mg), 9-hour intravenous infusion once on Day 1, Treatment Period 1 followed by 24 hours wash-out period, followed by TAK-925 placebo-matching 9-hour intravenous infusion once on Day 3, Treatment Period 2. Placebo + TAK-925 Dose A TAK-925 Placebo TAK-925 placebo-matching 9-hour intravenous infusion once on Day 1, Treatment Period 1 followed by 24 hours wash-out period, followed by, TAK-925 112 mg, 9-hour intravenous infusion once on Day 3, Treatment Period 2. Placebo + TAK-925 Dose A TAK-925 TAK-925 placebo-matching 9-hour intravenous infusion once on Day 1, Treatment Period 1 followed by 24 hours wash-out period, followed by, TAK-925 112 mg, 9-hour intravenous infusion once on Day 3, Treatment Period 2.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) Study Day 1 up to Study Day 11 Percentage of Participants With Markedly Abnormal Criteria for Clinical Safety Laboratory Tests Study Day 1 up to Study Day 11 Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements From Predose up to Study Day 4 Percentage of Participants With Markedly Abnormal Criteria for 12-lead Safety Electrocardiogram (ECG) Parameters Study Day 1 up to Study Day 4
- Secondary Outcome Measures
Name Time Method AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 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 AUC Last: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-925 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 Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925 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
Trial Locations
- Locations (22)
Preferred Research Partners, Inc.
🇺🇸Little Rock, Arkansas, United States
SOUSEIKAI PS Clinic
🇯🇵Hakata-ku, Fukuoka-Ken, Japan
Pulmonary Associates Clinical Trials
🇺🇸Glendale, Arizona, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders"
🇺🇸Chevy Chase, Maryland, United States
Bogan Sleep Consultants, LLC
🇺🇸Columbia, South Carolina, United States
Wright Clinical Research
🇺🇸Alabaster, Alabama, United States
Global Research Associates
🇺🇸Stockbridge, Georgia, United States
Sumida Hospital
🇯🇵Sumida-ku, Tokyo-To, Japan
Delta Waves Sleep Disorders and Research Center
🇺🇸Colorado Springs, Colorado, United States
Stanford School of Medicine
🇺🇸Redwood City, California, United States
Pacific Research Network, Inc
🇺🇸San Diego, California, United States
Pulmonary Disease Specialists, PA, d/b/a PDS Research
🇺🇸Kissimmee, Florida, United States
Florida Pulmonary Research Institute, LLC
🇺🇸Winter Park, Florida, United States
NeuroTrials Research, Inc.
🇺🇸Atlanta, Georgia, United States
CTI Clinical Trial and Consulting Services
🇺🇸Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Sleep Therapy & Research Center
🇺🇸San Antonio, Texas, United States
St Francis Medical Institute
🇺🇸Clearwater, Florida, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Research Centers of America
🇺🇸Hollywood, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States