Phase 1 TAK-925 Study in Healthy Adult and Elderly Volunteers and Patients with Narcolepsy

Phase 1

Completed

• Conditions: Healthy Participants and Patients with Narcolepsy

• Registration Number: JPRN-jRCT2080223700
• Lead Sponsor: TAKEDA PHARMACEUTICAL COMPANY LTD.

Brief Summary

TAK-925 was considered to be safe and tolerable over the tested dose ranges both in healthy subjects and NT1 patients.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-02
• Study Completion: 2018-09-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 58

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified