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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 NT1
EU CTIS ID: 2025-522034-31-00
What this study is testing
To determine the plasma pharmacokinetic (PK) parameters of oveporexton in pediatric participants.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The participant has an ICSD-3 or ICSD-3-TR diagnosis of NT1.
- Male or female participants aged 6 to 17 years, inclusive, at the time of signing the ICF.
- The participant has a body mass index within the range 18 to 30 kg/m2
- The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1*06:02 or results from radioimmunoassay indicate the participant’s CSF OX/hypocretin-1 concentration is <110 pg/mL
- The participant is judged by the investigator to be sufficiently healthy to participate in the trial based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the screening visit and before the first dose of trial intervention.
- Parent or legal guardian – and participants old enough to understand - have expressed a willingness to participate in and complete the trial and signed and dated the ICF after getting acquainted with the participant’s information sheet, prior to beginning protocol-required procedures.
You likely can't join if
- Participant is unable to refrain from using excluded medications
- The participant has a positive urine screen result for drugs of abuse and/or positive alcohol test result at screening or at Day -1.
- Participant has a positive pregnancy test result at screening or is breastfeeding.
- Participant has a known hypersensitivity to any component of the formulation of oveporexton or related compounds.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.