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NCT04122755 · ClinicalTrials.gov registry record · Phase 1
Single Ascending Dose Study of ALA-1000
A Phase 1 study, sponsored by Alar Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
NCT04122755 is a Phase 1 study that has completed, run by Alar Pharmaceuticals. The registered enrollment target is 59 participants.
The verdict
NCT04122755, a Phase 1 study, has completed, sponsored by Alar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
Study Summary
An open-label study designed to evaluate the safety, tolerability, and pharmacokinetics of ALA-1000 in opioid-dependent subjects. To characterize the PK profile of ALA-1000 in 5 single ascending dose cohorts and a sixth cohort of single ALA-1000 after receiving buprenorphine sublingual films for 7 days.
Interventions
- DRUG ALA-1000
- DRUG buprenorphine sublingual film
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2019-09-16 |
| Est. Completion | 2021-05-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04122755
The ClinicalTrials.gov registry entry for NCT04122755 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alar Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ALA-1000 is the first listed.
NCT04122755 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04122755 about?
NCT04122755 is a clinical study titled "Single Ascending Dose Study of ALA-1000". An open-label study designed to evaluate the safety, tolerability, and pharmacokinetics of ALA-1000 in opioid-dependent subjects. To characterize the PK profile of ALA-1000 in 5 single ascending dose cohorts and a sixth cohort of single ALA-1000 after receiving buprenorphine sublingual films for 7 d...
What is the current status of trial NCT04122755?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2019-09-16. Estimated completion is 2021-05-03.
What interventions are being tested in trial NCT04122755?
The interventions under investigation include: ALA-1000 (DRUG), buprenorphine sublingual film (DRUG).
Who is sponsoring clinical trial NCT04122755?
This trial is sponsored by Alar Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
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