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NCT03701555 · ClinicalTrials.gov registry record · Phase 1
A Study of PVP001, PVP002, and PVP003 in Healthy Adults and PVP001 and PVP002 in Adults With Celiac Disease
A Phase 1 study of Digestive System Disease, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 139
- Enrollment target
- 1
- Study location
NCT03701555: Completed Phase 1 study of Digestive System Disease, sponsored by Millennium Pharmaceuticals.
NCT03701555 is a Phase 1 study of Digestive System Disease that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 139 participants, below the 2,432-participant average among 4 other Digestive System Disease trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03701555, a Phase 1 study of Digestive System Disease, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 139 participants
- Enrollment target
- 1
- Study location
Study Summary
It is hoped that different forms of the same medicine, called PVP001, PVP002, and PVP003, will help people with celiac disease. Both healthy adults and adults with celiac disease will take part in this study. There are many main aims of the study. * To check if participants have side effects from different forms of the study medicine. These forms are called PVP001 (liquid in a cup), PVP002 capsule, and PVP003 tablet. * To check how well PVP003 breaks down gluten. * To check how much PVP003 participants can take without getting side effects from it. The study is in 4 parts. At the start of each part of the study, the study doctor will check to determine who can take part at the first study visit. Different groups of participants will be in different parts of the study. In all parts of the study, some participants will take 1 of the 3 forms of study medicine. Others will take a placebo. In this study, a placebo will look like the form of study medicine but will not have any medicine in it. This means that a placebo can either look like PVP001 liquid in a cup, the PVP002 tablet, or the PVP003 tablet. In Part 1, different small groups of participants will take lower to higher doses of PVP001 or PVP002 or a placebo. This is to work out the best dose of study medicine to take in other parts of the study. After treatment, participants will regularly visit the clinic to check that they have no problems with their treatment, including any side effects from their treatment. In Part 2, different small groups will take different doses of PVP001 or PVP002 or a placebo, either with or without a meal that has different amounts of gluten in it. This is to check if PVP001 or PVP002 has broken down gluten in the body. Participants will visit the clinic after treatment to check how much gluten has been broken down in the body. In Part 3, different small groups will take different doses of PVP003 or a placebo, either with or without a meal that has gluten in it. This is to check
Conditions Studied
Interventions
- OTHER PvP001 placebo
- DRUG PvP001 100 mg
- DRUG PvP001 300 mg
- DRUG PvP001 900 mg
- DRUG Maximum Feasible Dose (MFD) of PvP002
Study Locations (1)
California
- Anaheim Clinical Trials - Anaheim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2018-06-19 |
| Est. Completion | 2021-07-02 |
| Phase | Phase 1 |
What the finished NCT03701555 record still lists
NCT03701555 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 2,432-participant average among 4 other Digestive System Disease trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Digestive System Disease appearing as the primary indexed condition, and to 5 interventions - of which PvP001 placebo is the first listed.
NCT03701555 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03701555 about?
NCT03701555 is a clinical study titled "A Study of PVP001, PVP002, and PVP003 in Healthy Adults and PVP001 and PVP002 in Adults With Celiac Disease". It is hoped that different forms of the same medicine, called PVP001, PVP002, and PVP003, will help people with celiac disease. Both healthy adults and adults with celiac disease will take part in this study. There are many main aims of the study. * To check if participants have side effects from ...
What is the current status of trial NCT03701555?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 139 participants. The study started on 2018-06-19. Estimated completion is 2021-07-02.
What conditions does trial NCT03701555 study?
This clinical trial studies the following conditions: Digestive System Disease.
What interventions are being tested in trial NCT03701555?
The interventions under investigation include: PvP001 placebo (OTHER), PvP001 100 mg (DRUG), PvP001 300 mg (DRUG), PvP001 900 mg (DRUG), Maximum Feasible Dose (MFD) of PvP002 (DRUG).
Who is sponsoring clinical trial NCT03701555?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03701555 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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