A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants with Narcolepsy

Phase 1

Completed

• Conditions: Healthy Participants and Patients with Narcolepsy

• Registration Number: JPRN-jRCT2080224146
• Lead Sponsor: TAKEDA PHARMACEUTICAL COMPANY LTD.

Brief Summary

TAK-925 was safe and well tolerated in the multiple intravenous administrations of up to 180 mg for healthy participants, up to 44 mg for patients with NT1, and up to 112 mg for patients with NT2; and also in single oral administration of 112 mg for healthy participants.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-16
• Study Completion: 2019-10-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 57

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 (>=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 Criteria

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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified