Open-label single dose trial to evaluate pharmacokinetics, safety, and acceptability/palatability of oveporexton in children from 6 years to less than 18 years of age with narcolepsy type 1 (NT1)

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522034-31-00

Acronym

TAK-861-1012

Enrollment

Registered

2025-11-27

Start date

2026-01-07

Completion date

Unknown

Last updated

2025-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Narcolepsy with Cataplexy (Narcolepsy Type 1)

Brief summary

Maximum observed concentration (Cmax). Time to reach maximum observed concentration (tmax). Area under the concentration-time curve from time 0 to infinity (AUC∞), calculated using the observed value of the last quantifiable concentration.

Detailed description

Occurrence of at least 1 TEAE., Participants rating acceptability and palatability.

Interventions

DRUGTAK-861

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Maximum observed concentration (Cmax). Time to reach maximum observed concentration (tmax). Area under the concentration-time curve from time 0 to infinity (AUC∞), calculated using the observed value of the last quantifiable concentration.	—

Secondary

Measure	Time frame
Occurrence of at least 1 TEAE., Participants rating acceptability and palatability.	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026