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NCT03594331 · ClinicalTrials.gov registry record · Phase 1
Gastric Gluten-Degradation Activity of PvP001
A Phase 1 study, sponsored by Danielle Kim Turgeon.
- Terminated
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT03594331 is a Phase 1 study that was terminated before completion, run by Danielle Kim Turgeon. The registered enrollment target is 43 participants.
The verdict
NCT03594331, a Phase 1 study, was terminated before completion, sponsored by Danielle Kim Turgeon.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
This is a single blind, dose escalating, placebo-controlled, crossover study of gluten-degrading drug PvP001 administered to healthy volunteers (age 18-64 years). Subjects will be randomized to one of three groups representing different levels of gluten exposure - low, medium, or high - in a single meal. Within each gluten exposure group, increasing doses of PvP001 (or placebo) will be administered.
Interventions
- DRUG Placebo
- DRUG Low-dose PvP001
- DRUG Medium-dose PvP001
- DRUG High-dose PvP001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2018-05-25 |
| Est. Completion | 2019-02-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03594331
The ClinicalTrials.gov registry entry for NCT03594331 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Danielle Kim Turgeon, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03594331 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03594331 about?
NCT03594331 is a clinical study titled "Gastric Gluten-Degradation Activity of PvP001". This is a single blind, dose escalating, placebo-controlled, crossover study of gluten-degrading drug PvP001 administered to healthy volunteers (age 18-64 years). Subjects will be randomized to one of three groups representing different levels of gluten exposure - low, medium, or high - in a single ...
What is the current status of trial NCT03594331?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2018-05-25. Estimated completion is 2019-02-06.
What interventions are being tested in trial NCT03594331?
The interventions under investigation include: Placebo (DRUG), Low-dose PvP001 (DRUG), Medium-dose PvP001 (DRUG), High-dose PvP001 (DRUG).
Who is sponsoring clinical trial NCT03594331?
This trial is sponsored by Danielle Kim Turgeon, which has 4 total clinical trials registered on ClinicalTrials.gov.
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