Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy
Lead Sponsor:
Takeda
Conditions:
Healthy Participants
Narcolepsy
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy participants.
Detailed Description
The drug being tested in this study is called TAK-925. TAK-925 is being tested in healthy participants and participants with narcolepsy. This study will look at the safety, tolerability, pharmacokinet...
Eligibility Criteria
Inclusion
- Healthy adult participants and Healthy elderly participants:
- • Participant weighs at least 50 kg (Healthy adults participants) / 40 kilogram (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 participants:
- Participants weighs at least 40 kg inclusive at Screening (\>=50 kg is required for Cohort B4).
- A diagnosis of narcolepsy, as defined by the International Classification of Sleep Disorders, Third Edition (ICSD-3).
- At Day -1, Epworth sleepiness scale (ESS) score \>=10
Exclusion
- All Participants:
- Participants consume excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
- Participants have a moderate to severe substance use disorder.
- Participants have a risk of suicide according to endorsement of item 4 or 5 with Screening/Baseline visit C-SSRS (Columbia Suicide Severity Rating Scale) or has made a suicide attempt in the previous 6 months.
- Participants have a lifetime history of major psychiatric disorder, such as bipolar disorder or schizophrenia.
- Participants experienced sleep wake cycle disturbance with external factors such as irregular work hours.
Key Trial Info
Start Date :
November 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2019
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03748979
Start Date
November 21 2018
End Date
October 24 2019
Last Update
December 8 2020
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Sumida Hospital
Sumida-ku, Tokyo, Japan
2
Hakata Clinic
Fukuoka, Japan
3
PS Clinic
Fukuoka, Japan