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NCT03594331
Gastric Gluten-Degradation Activity of PvP001
Phase 1 trial testing Low-dose PvP001 in Digestive System Disease in 43 participants. Terminated before completion.
6 February 2019
Quick facts
| Lead sponsor | Danielle Kim Turgeon |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 43 |
| Start date | 25 May 2018 |
| Primary completion | 6 February 2019 |
| Estimated completion | 6 February 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Low-dose PvP001 — full drug profile →
- Medium-dose PvP001 — full drug profile →
- High-dose PvP001 — full drug profile →
- Placebo
Conditions studied
- Digestive System Disease — all drugs for Digestive System Disease →
Sponsor
Danielle Kim Turgeon — full company profile →
Who can join
Adults 18 to 64, any sex, with Digestive System Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03594331
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Danielle Kim Turgeon trials
Trials by the same sponsor.
- NCT04304781 — Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer · Phase 1 · terminated
- NCT03148119 — Study of QRH-882260 Heptapeptide Application in the Colon · Phase 1 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03594331 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Danielle Kim Turgeon
- Last refreshed: 15 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03594331.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing