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NCT04331288 · ClinicalTrials.gov registry record · Phase 1
Effects of Ethanol on the Pharmacokinetics of PT-150 (Formerly ORG34517) (PT150 PK Study)
A Phase 1 study, sponsored by Pop Test Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT04331288: Completed Phase 1 study, sponsored by Pop Test Oncology.
NCT04331288 is a Phase 1 study that has completed, run by Pop Test Oncology. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04331288, a Phase 1 study, has completed, sponsored by Pop Test Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The purpose of this clinical study is to assess pharmacokinetic interactions between ethanol (EtOH) and PT150 (900 mg qd) in non-treatment-seeking alcohol-experienced volunteers-(to include military service members, veterans and/or civilians).
Primary Outcome
Estimates of maximum concentration (Cmax) of PT150 will be calculated and compared from PT150 steady state alone (days 6-7) to concurrent steady state of PT150 with ethanol exposure (days 7-9).
Interventions
- DRUG PT150
- OTHER Beverage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2023-10-27 |
| Phase | Phase 1 |
What the finished NCT04331288 record still lists
NCT04331288 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which PT150 is the first listed.
NCT04331288 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04331288 about?
NCT04331288 is a clinical study titled "Effects of Ethanol on the Pharmacokinetics of PT-150 (Formerly ORG34517) (PT150 PK Study)". The purpose of this clinical study is to assess pharmacokinetic interactions between ethanol (EtOH) and PT150 (900 mg qd) in non-treatment-seeking alcohol-experienced volunteers-(to include military service members, veterans and/or civilians).
What is the current status of trial NCT04331288?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2021-11-01. Estimated completion is 2023-10-27.
What interventions are being tested in trial NCT04331288?
The interventions under investigation include: PT150 (DRUG), Beverage (OTHER).
Who is sponsoring clinical trial NCT04331288?
This trial is sponsored by Pop Test Oncology, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04331288's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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