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Gastric Gluten-Degradation Activity of PvP001

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03594331
Recruitment Status : Terminated (Funding stopped)
First Posted : July 20, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
PvP Biologics, Inc.
Information provided by (Responsible Party):
Danielle Kim Turgeon, University of Michigan

Tracking Information
First Submitted Date  ICMJE June 21, 2018
First Posted Date  ICMJE July 20, 2018
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE May 25, 2018
Actual Primary Completion Date February 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gastric Gluten-Degradation Activity of PvP001
Official Title  ICMJE A Phase I, First-in-Human Single Center Study in Healthy Adult Volunteers to Assess the Gastric Gluten-Degradation Activity of PvP001
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Digestive System Disease
Intervention  ICMJE
  • Drug: Low-dose PvP001
    Low-dose PvP001
  • Drug: Medium-dose PvP001
    Medium-dose PvP001
  • Drug: High-dose PvP001
    High-dose PvP001
  • Drug: Placebo
    100 mL liquid with no drug
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Low-dose PvP001
    • Drug: Medium-dose PvP001
    • Drug: High-dose PvP001
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Low-dose PvP001
    • Drug: Medium-dose PvP001
    • Drug: High-dose PvP001
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Low-dose PvP001
    • Drug: Medium-dose PvP001
    • Drug: High-dose PvP001
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 10, 2019)
43
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2018)
30
Actual Study Completion Date  ICMJE February 6, 2019
Actual Primary Completion Date February 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03594331
Other Study ID Numbers  ICMJE HUM00122254
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Danielle Kim Turgeon, University of Michigan
Study Sponsor  ICMJE Danielle Kim Turgeon
Collaborators  ICMJE PvP Biologics, Inc.
Investigators  ICMJE
Principal Investigator: Danielle Kim Turgeon, MD University of Michigan
PRS Account University of Michigan
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP