Trials / Terminated
TerminatedNCT04049578
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children With Autism Spectrum Disorder
A Phase Ib, Multicenter, Open-Label, 6-Week Study With a 48-Week Extension to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children Ages 2-4 Years With Autism Spectrum Disorder
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 2 Years – 4 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Balovaptan | Participants were to receive an oral dose of balovaptan once a day (QD) for a 6-week treatment period, followed by an optional extension period of 48 weeks. |
Timeline
- Start date
- 2019-12-19
- Primary completion
- 2020-04-23
- Completion
- 2020-05-06
- First posted
- 2019-08-08
- Last updated
- 2020-10-14
- Results posted
- 2020-10-14
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04049578. Inclusion in this directory is not an endorsement.