Digestive System DiseasePhase 1NCT03594331
Gastric Gluten-Degradation Activity of PvP001
A Phase 1 study testing Low-dose PvP001, Medium-dose PvP001 and High-dose PvP001 in people with Digestive System Disease, run by Danielle Kim Turgeon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive System Disease
- What is being tested?
- Low-dose PvP001, Medium-dose PvP001 and High-dose PvP001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2018to 6 Feb 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Digestive System Disease
- Being tested
- Low-dose PvP001, Medium-dose PvP001, High-dose PvP001, Placebo
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose PvP001Drug
Low-dose PvP001
Medium-dose PvP001Drug
Medium-dose PvP001
High-dose PvP001Drug
High-dose PvP001
PlaceboDrug
100 mL liquid with no drug
| Study group | Role | What they receive |
|---|---|---|
| Gluten Exposure Group 1 | Experimental | 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. Receives: Drug: Low-dose PvP001; Drug: Medium-dose PvP001; Drug: High-dose PvP001; Drug: Placebo |
| Gluten Exposure Group 2 | Experimental | 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. Receives: Drug: Low-dose PvP001; Drug: Medium-dose PvP001; Drug: High-dose PvP001; Drug: Placebo |
| Gluten Exposure Group 3 | Experimental | 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. Receives: Drug: Low-dose PvP001; Drug: Medium-dose PvP001; Drug: High-dose PvP001; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events
The number of treatment emergent adverse events at each dosage level
Measured: 2 weeks from each exposure.
Percentage of treatment emergent adverse events
The percentage of treatment emergent adverse events at each dosage level
Measured: 2 weeks from each exposure.
Side effects of study drug
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.
Measured: 12 months
Efficacy as measured by the lowest dose to degrade highest amount of gluten
The lowest dose of PvP001 that degrades the highest amount of gluten in a standardized study meal
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start25 May 2018
- Primary completion6 Feb 2019
- Study completion6 Feb 2019
Why it stopped: Funding stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danielle Kim Turgeon
- Sponsor type
- University, hospital or other
- Collaborators
- PvP Biologics, Inc.
- Responsible party
- Sponsor-investigator, Danielle Kim Turgeon, University of Michigan
- Investigators
- Danielle Kim Turgeon, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594331
- Sponsor's protocol ID
- HUM00122254
- Status last verified
- Feb 2019
- First submitted
- 21 Jun 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, First-in-Human Single Center Study in Healthy Adult Volunteers to Assess the Gastric Gluten-Degradation Activity of PvP001
- ClinicalTrials.gov ID
- NCT03594331
- Acronym / sponsor ID
- HUM00122254
- Conditions
- Digestive System Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding stopped
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Danielle Kim TurgeonUniversity, hospital or other
- Collaborators
- PvP Biologics, Inc.
- Study start
- 25 May 2018 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gluten Exposure Group 1 | Experimental | Drug: Low-dose PvP001, Drug: Medium-dose PvP001, Drug: High-dose PvP001, Drug: PlaceboThis 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. |
| Gluten Exposure Group 2 | Experimental | Drug: Low-dose PvP001, Drug: Medium-dose PvP001, Drug: High-dose PvP001, Drug: PlaceboThis 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. |
| Gluten Exposure Group 3 | Experimental | Drug: Low-dose PvP001, Drug: Medium-dose PvP001, Drug: High-dose PvP001, Drug: PlaceboThis 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose PvP001Low-dose PvP001 | Drug | Gluten Exposure Group 1, Gluten Exposure Group 2, Gluten Exposure Group 3 |
| Medium-dose PvP001Medium-dose PvP001 | Drug | Gluten Exposure Group 1, Gluten Exposure Group 2, Gluten Exposure Group 3 |
| High-dose PvP001High-dose PvP001 | Drug | Gluten Exposure Group 1, Gluten Exposure Group 2, Gluten Exposure Group 3 |
| Placebo100 mL liquid with no drug | Drug | Gluten Exposure Group 1, Gluten Exposure Group 2, Gluten Exposure Group 3 |
Primary outcome
Number of treatment emergent adverse events
Time frame: 2 weeks from each exposure.
The number of treatment emergent adverse events at each dosage level
Percentage of treatment emergent adverse events
Time frame: 2 weeks from each exposure.
The percentage of treatment emergent adverse events at each dosage level
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.
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
Results and safety
The study was stopped early (reason given: Funding stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Kim Turgeon, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low-dose PvP001, Medium-dose PvP001 and High-dose PvP001 in people with Digestive System Disease, run by Danielle Kim Turgeon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding stopped). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment emergent adverse events (time frame: 2 weeks from each exposure.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.