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NCT04782388 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety, Tolerability, And Pharmacokinetics of Staccato Alprazolam in Healthy Japanese, Chinese, and Caucasian Participants
A Phase 1 study of Healthy Study Participants, sponsored by UCB Biopharma SRL.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04782388: Completed Phase 1 study of Healthy Study Participants, sponsored by UCB Biopharma SRL.
NCT04782388 is a Phase 1 study of Healthy Study Participants that has completed, run by UCB Biopharma SRL. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04782388, a Phase 1 study of Healthy Study Participants, has completed, sponsored by UCB Biopharma SRL.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of Staccato alprazolam in healthy Japanese, Chinese, and Caucasian participants.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. The occurrence and incidence of TEAEs will also be summarized by intensity and by relationship to the investigational medicinal product (IMP).
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Alprazolam
Study Locations (1)
California
- Up0101 101 - Anaheim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-03-04 |
| Est. Completion | 2021-04-26 |
| Phase | Phase 1 |
What the finished NCT04782388 record still lists
NCT04782388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Healthy Study Participants appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04782388 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04782388 about?
NCT04782388 is a clinical study titled "Study to Assess the Safety, Tolerability, And Pharmacokinetics of Staccato Alprazolam in Healthy Japanese, Chinese, and Caucasian Participants". The purpose of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of Staccato alprazolam in healthy Japanese, Chinese, and Caucasian participants.
What is the current status of trial NCT04782388?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-03-04. Estimated completion is 2021-04-26.
What conditions does trial NCT04782388 study?
This clinical trial studies the following conditions: Healthy Study Participants.
What interventions are being tested in trial NCT04782388?
The interventions under investigation include: Placebo (OTHER), Alprazolam (DRUG).
Who is sponsoring clinical trial NCT04782388?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04782388 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04782388's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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