Trials / Completed
CompletedNCT04857307
A Study to Assess the Pharmacokinetics (PK) and Safety of Staccato Alprazolam in Adolescent Study Participants With Epilepsy
A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Tolerability, and Safety of a Single Dose of Staccato Alprazolam in Adolescent Study Participants With Epilepsy
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- UCB Biopharma SRL · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to assess the pharmacokinetics (PK), tolerability, and safety of Staccato alprazolam in adolescent study participants with epilepsy following single-dose administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Alprazolam | * Pharmaceutical form: Inhalation powder. * Study participants will receive Staccato alprazolam at prespecified time-points. |
Timeline
- Start date
- 2021-04-28
- Primary completion
- 2022-04-05
- Completion
- 2022-04-05
- First posted
- 2021-04-23
- Last updated
- 2022-06-30
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04857307. Inclusion in this directory is not an endorsement.