- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03594331
Gastric Gluten-Degradation Activity of PvP001
February 10, 2019 updated by: Danielle Kim Turgeon
A Phase I, First-in-Human Single Center Study in Healthy Adult Volunteers to Assess the 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 meal.
Within each gluten exposure group, increasing doses of PvP001 (or placebo) will be administered.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Michigan Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers;
- Able to maintain a gluten-free diet (GFD) for 24 hours prior to each of visits 1-4;
- Able to abstain from alcohol consumption 72 hours before and 72 hours after each visit;
- Able to tolerate the placement, presence, and manipulation of an oro-gastro-duodenal (OGD) tube;
- Women of child-bearing potential and men whose partners are women of child-bearing potential must be willing to use acceptable birth control for the duration of the study;
- Able to read and understand English;
- Able to provide written informed consent
Exclusion Criteria:
- Any condition or abnormality, current or past, that, in the opinion of the investigator, would compromise the safety of the subject, or would interfere with or complicate study procedures or assessments.
- No current or recent (within 14 days prior to each study visit, clinical laboratory testing, and ECG) use of over-the-counter or prescription medications via any route of administration, except for oral contraceptives for birth control (provided they have been used regularly for at least the past 3 months). Other medications used regularly at stable doses may be acceptable at the discretion of the study doctor.
- Current symptoms of congestion, upper respiratory tract infection, or acute illness
- Chronic viral infection or immunodeficiency condition
- Any female who is pregnant, planning to become pregnant during the study, or breast-feeding
- History of intolerance, hypersensitivity, or reaction to wheat or other grains, gluten, or any other food or food ingredient (including an additive or preservative) in the study meal;
- Receipt of an investigational medication within four weeks prior to the screening visit or from the screening visit through the final visit;
- Alcohol consumption >5 drinks/week or any alcohol consumption within the 72 hours prior to each study exposure visit or a positive breathalyzer test result at any study visit;
- Illicit or recreational drug use in the past 12 months or positive urine drug screen at the screening visit;
- History of smoking, nicotine, or tobacco use in the past 12 months;
- History or high risk of noncompliance with treatment or visits.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Gluten Exposure Group 1
This group will ingest the drug and then consume a study meal containing a low level of gluten.
In four separate visits, each subject will be administered low-dose PvP001, medium-dose PvP001, high-dose PvP001 and placebo, with blinding to the dose of PvP001 and to which visit placebo is given.
|
Low-dose PvP001
Medium-dose PvP001
High-dose PvP001
100 mL liquid with no drug
|
EXPERIMENTAL: Gluten Exposure Group 2
This group will ingest the drug and then consume a study meal containing a medium level of gluten.
In four separate visits, each subject will be administered low-dose PvP001, medium-dose PvP001, high-dose PvP001 and placebo, to the dose of PvP001 and to which visit placebo is given.
|
Low-dose PvP001
Medium-dose PvP001
High-dose PvP001
100 mL liquid with no drug
|
EXPERIMENTAL: Gluten Exposure Group 3
This group will ingest the drug and then consume a study meal containing a high level of gluten.
In four separate visits, each subject will be administered low-dose PvP001, medium-dose PvP001, high-dose PvP001 and placebo, with blinding to the dose of PvP001 and to which visit placebo is given.
|
Low-dose PvP001
Medium-dose PvP001
High-dose PvP001
100 mL liquid with no drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of treatment emergent adverse events
Time Frame: 2 weeks from each exposure.
|
The number of treatment emergent adverse events at each dosage level
|
2 weeks from each exposure.
|
Percentage of treatment emergent adverse events
Time Frame: 2 weeks from each exposure.
|
The percentage of treatment emergent adverse events at each dosage level
|
2 weeks from each exposure.
|
Side effects of study drug
Time Frame: 12 months
|
Side effects are assessed by the PI using a 5-scale, 9-question Gastrointestinal Symptoms Questionnaire (GSQ) to be self-administered by the subject at 16 time-points throughout the five-visit (including screening) study.
Each of the 9 questions will be given a numerical score (0-4 where 0 is none and 4 is very severe) and compared to baseline score and placebo scores any increase of >1 point over the average baseline and placebo score will be considered an AE and graded based on the severity reported.
|
12 months
|
Efficacy as measured by the lowest dose to degrade highest amount of gluten
Time Frame: 12 months
|
The lowest dose of PvP001 that degrades the highest amount of gluten in a standardized study meal
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 25, 2018
Primary Completion (ACTUAL)
February 6, 2019
Study Completion (ACTUAL)
February 6, 2019
Study Registration Dates
First Submitted
June 21, 2018
First Submitted That Met QC Criteria
July 19, 2018
First Posted (ACTUAL)
July 20, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 15, 2019
Last Update Submitted That Met QC Criteria
February 10, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00122254
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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