Status:
COMPLETED
Phase 1 TAK-925 Study in Healthy Adult and Elderly Volunteers and Participants With Narcolepsy
Lead Sponsor:
Takeda
Conditions:
Healthy Participants and Patients With Narcolepsy
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate safety, tolerability, and pharmacokinetics of TAK-925 when a single dose of TAK-925 is administered to healthy adult participants, healthy elderly participa...
Detailed Description
Orexins are neuropeptides that play a role in the regulation of sleep and wakefulness. In type 1 narcolepsy, there is a loss of orexin producing neurons in the brain. The investigational drug, TAK-925...
Eligibility Criteria
Inclusion
- Healthy adult participants and Healthy elderly participants:
- \- Participant weighs at least 50 kilogram (kg) (Healthy adults participants) / 40 kg (Healthy elderly participants) and has a body mass index (BMI) from 18.5 to 30 kilogram per square meter (kg/m\^2), inclusive at Screening.
- Narcolepsy patients:
- Patient weighs at least 40 kg inclusive at Screening.
- A diagnosis of narcolepsy Type 1, as defined by the International Classification of Sleep Disorders, Third Edition (ICSD-3).
- HLA narcolepsy test positivity.
- At Day -1, Epworth sleepiness scale (ESS) score greater than or equal to (\>=) 10
- Blood pressure less than (\<) 140 systolic and \< 90 diastolic. The patient may have a history of hypertension and be on antihypertensive medication treatment as long as the BP meets these criteria.
Exclusion
- All Participants:
- Participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the Screening visit.
- Past or current epilepsy, convulsion, tremor or the disorders of related symptoms.
- Has a lifetime history of major psychiatric disorder, such as major depressive disorder, bipolar disorder, or schizophrenia.
- HV (only Cohort 4):
- \- Participant has had CSF collection performed within 14 days prior to check-in (Day -1).
- Narcolepsy patients
- Medical disorder associated with excessive sleepiness other than narcolepsy (including sleep apnea syndrome).
- Excessive caffeine (greater than \[\>\] 400 milligram per day \[mg/day\]) use one week prior to study.
Key Trial Info
Start Date :
November 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2018
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03332784
Start Date
November 4 2017
End Date
September 4 2018
Last Update
March 30 2021
Active Locations (3)
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1
Sumida Hospital
Sumida-ku, Tokyo, Japan
2
Hakata Clinic
Fukuoka, Japan
3
PS Clinic
Fukuoka, Japan