Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04049578 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children With Autism Spectrum Disorder
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT04049578 is a Phase 1 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 2 participants.
The verdict
NCT04049578, a Phase 1 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This was a Phase Ib, multicenter, open-label study in children 2-4 years old with autism spectrum disorder (ASD) to investigate the pharmacokinetics, safety, and tolerability of an oral dose of balovaptan once a day (QD). The study was to consists of a 6-week treatment period to evaluate the pharmacokinetics of balovaptan in 2 to 4 year old children followed by an optional extension period of 48 weeks.
Interventions
- DRUG Balovaptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2019-12-19 |
| Est. Completion | 2020-05-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04049578
The ClinicalTrials.gov registry entry for NCT04049578 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Balovaptan is the first listed.
NCT04049578 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04049578 about?
NCT04049578 is a clinical study titled "A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children With Autism Spectrum Disorder". This was a Phase Ib, multicenter, open-label study in children 2-4 years old with autism spectrum disorder (ASD) to investigate the pharmacokinetics, safety, and tolerability of an oral dose of balovaptan once a day (QD). The study was to consists of a 6-week treatment period to evaluate the pharmac...
What is the current status of trial NCT04049578?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2019-12-19. Estimated completion is 2020-05-06.
What interventions are being tested in trial NCT04049578?
The interventions under investigation include: Balovaptan (DRUG).
Who is sponsoring clinical trial NCT04049578?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.