Healthy Participants and Patients with Narcolepsy
Conditions
Interventions
Dose Level 1, 3, 5, Cohort 2
Dose Level 2, 4, 6, Cohort 3-4
Dose Level 5)
Intravenous single administration. Healthy adults (Cohort 1, 2)/ healthy elderly participants (Cohort 3) will be enrolled in double blind manner and healthy adults (Cohort 4) will be enrolled in non-b
Intravenous single administration. Patients with Narcolepsy will be enrolled in double blind manner (sponsor open) in Part 2.
control material(s)
Generic name etc : Placebo
INN of investigational mat
Intravenous single administration. Healthy adults (Cohort 1, 2)/ healthy elderly participants (Cohort 3) will be enrolled in double blind manner in Part 1. Part 2: Placebo (Cohort 5-7)
Intravenous single administration. Patients with Narcolepsy will be enrolled in double blind manner (sponsor open) in Part 2.
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy adult participants and Healthy elderly participants: - Participant weighs at least 50 kg (Healthy adults participants) / 40 kg (Healthy elderly participants) and has a body mass index (BMI) from 18.5 to 30 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). - A patient who is positive for HLA-DQB106:02 - At Day -1, Epworth sleepiness scale (ESS) score >=10 - Blood pressure <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 criteria
Exclusion criteria: 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, seizure, 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 (>400mg/day) use one week prior to study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAE) Timeframe; Baseline up to Day 7 safety Number of Participants who Experience at Least One TEAE Related to Vital Signs Timeframe; Baseline up to Day 7 safety Number of Participants who Experience at Least One TEAE Related to Body Weight Timeframe; Baseline up to Day 7 safety Number of Participants who Experience at Least One TEAE Related to 12-lead electrocardiogram (ECG) Timeframe; Baseline up to Day 7 safety Number of Participants who Experience at Least One TEAE Related to Clinical Laboratory Tests Timeframe; Baseline up to Day 7 pharmacokinetics Part 1,AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and its Metabolites M1 and M2 Time Frame: Day 1 pre-infusion and at, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion pharmacokinetics Part 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and its Metabolites M1 and M2 Time Frame: Days 1-4; pre-infusion and at, 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion pharmacokinetics Part 1, AUC(infinity): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-925 and its Metabolites M1 and M2 Time Frame: Day 1 pre-infusion and at, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion pharmacokinetics Part 2, AUC(infinity): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and its Metabolites M1 and M2 Time Frame: Days 1-4; pre-infusion and at, 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion pharmacokinetics Part 1, C | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Part 2:Average Sleep Latency in Maintenance of Wakefulness Test (MWT) The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.. Time Frame: Days 1 and 3 up to 8 hours following the start of infusion | — |
Countries
Japan
Outcome results
None listed