Digestive System DiseasePhase 1NCT03701555

A Study of PVP001, PVP002, and PVP003 in Healthy Adults and PVP001 and PVP002 in Adults With Celiac Disease

A Phase 1 study testing PvP001 100 mg, PvP001 300 mg and PvP001 900 mg in people with Digestive System Disease, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. 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?: PvP001 100 mg, PvP001 300 mg and PvP001 900 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 139 participants
Where: 1 siteUnited States
Study dates: 19 Jun 2018to 2 Jul 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Part 1, Part 2, Part 3 and Part 4
Male or female age 18- 64 years, inclusive
No relevant gastrointestinal symptoms
Able to abstain from alcohol for 72 hours prior to the Screening Visit; for 72 hours prior to and after the Cohort Treatment Day (Part 1, Part 2, and Part 3); for 72 hours prior to the Safety Visit (Part 2 and Part 3); and for 72 hours prior to Day 1 of the first Cohort Treatment Period through the Safety Visit (Part 4).
A female participant must have a negative pregnancy test at Screening and on Cohort Treatment Day -1 (Part 1, Part 2, and Part 3) or a negative pregnancy test at Screening and on Day -1 of each Cohort Treatment Period (Part 4), and must agree to continue acceptable birth control measures (example, abstinence, a stable hormonal contraceptive, double-barrier method, or vasectomy in partner) from the Screening Visit through the 28 ± 2 days. Follow Up ADA Blood Sampling Visit
A male participant must agree to use acceptable birth control measures (e.g., abstinence, latex condom, or vasectomy), or must have a female partner who will continue birth control measures (e.g., abstinence, a stable hormonal contraceptive, or double-barrier method) from the Screening Visit through the 28 ± 2 days Follow Up Anti-Drug Antibody Blood Sampling Visit

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Able to read and understand English
Able to provide written informed consent
Additional Inclusion Criteria for Part 1, Part 2, Part 3, and Part 4 Healthy Adult Volunteers
No use of over-the-counter or prescription medication, except for birth control medications for the duration of the study
No history of gastrointestinal diseases or disorders
No history of intolerance, sensitivity, or reactions to gluten or any other food or food ingredient
Able to maintain a gluten-free diet for 24 hours prior to the Cohort Treatment Day (Part 1, Part 2, and Part 3), or usually ingests meals three times a day (that is, breakfast, lunch, and dinner) and is able to continue doing so during each Cohort Treatment Period (Part 4)
Additional Inclusion Criteria for Part 1 Participants with Celiac Disease
Documented history of Celiac Disease in medical records
Maintaining a gluten-free diet for ≥6 months
No use of over-the-counter or prescription medication, except for birth control medications and those allowed by the study doctor, for the duration of the study.
No history of gastrointestinal diseases or disorders, other than Celiac Disease
No history of intolerance, hypersensitivity, or reaction to any food or food ingredient
Able to continue a gluten-free diet for the duration of the study

Who cannot join

Part 1, Part 2, Part 3, and Part 4
Current symptoms or signs of illness
Chronic viral infection or immunodeficiency condition
Any female who is pregnant, planning to become pregnant during the study, or breast-feeding; any male who is planning to father a child during the study
Receipt (or planned receipt) of another investigational medication within 4 weeks prior to the Screening Visit through the duration of the study
Alcohol consumption greater than (>) 5 drinks/week, alcohol consumption within 72 hours prior to any study visit (Part 1, Part 2, and Part 3), alcohol consumption within 72 hours prior to Day 1 of the first Cohort Treatment Period through the Safety Visit (Part 4), or a positive alcohol breathalyzer test at any study visit
History of illicit or recreational drug use within the three years prior to the Screening Visit, or a positive urine drug screen at any study visit
Use of tobacco or nicotine products, including smoking, smokeless tobacco, e-cigarettes, or nicotine replacement products within 12 months prior to the Screening Visit through the duration of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Anaheim Clinical Trials
Anaheim, California, 92801

Other trials in United States

About this study

Official title: A Phase 1, Four-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Gluten Degradation Activity of PvP001, PvP002, and PvP003 in Healthy Adult Volunteers and to Assess the Safety, Tolerability, and Pharmacokinetics of PvP001 and PvP002 in Adults With Celiac Disease

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 if PVP003 has broken down gluten in the body. Participants will visit the clinic after treatment to check if more gluten has broken down in the body.

In Part 4, different small groups will take PVP003 or placebo 3 times a day for 5 days. After treatment, participants will visit the clinic to check that they have no problems with their treatment, including any side effects from their treatment.

Read the detailed description

This study has four parts. Each part of the study begins with a Screening Period of up to 4 weeks to allow for completion of screening procedures and subject scheduling. Each participant will be screened by means of medical history, medication review, Gastrointestinal Symptoms Questionnaire (GSQ), physical examination, vital signs, weight, height, laboratory tests, and ECG. The GSQ is being used as a separate safety monitoring tool in this study to ensure that all gastrointestinal complaints are reported by the participant.

Following completion of all screening procedures, eligible participants will be enrolled in the study.

Part 1 of the study in healthy participants will be completed prior to enrollment of any subject in Part 2 of the study. A participant enrolled in Part 1 of the study will participate in one of five dose Cohorts. Enrollment of healthy participants and participants with CeD in each of the five dose Cohorts will occur sequentially, but each of these dose Cohorts will be open to enrollment only after demonstration of the safety and tolerability of the same dose level in healthy participants. A healthy participant enrolled in Part 2 of the study will participate in one of three groups; within Groups 1, 2 and 3 enrollment may occur in parallel. A healthy participant enrolled in Part 3 of the study will participate in one of five groups; within Groups 1 to 5 enrollment will occur sequentially. A healthy participant enrolled in Part 4 of the study will participate in two cohorts; enrollment in Part 4 may occur in parallel with enrollment in Part 3. Each participant will be randomized to one of two possible treatment order. Participants who participate in Part 1 or Part 2 of the study, and who are not ADA positive, may participate in Part 3 or Part 4 of the study. No other participants may participate in more than one Part/Group of the study.

Conditions: Digestive System Disease
Being tested: PvP001 placebo, PvP001 100 mg, PvP001 300 mg, PvP001 900 mg, Maximum Feasible Dose (MFD) of PvP002
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.

PvP001 placeboOther
placebo
PvP001 100 mgDrug
PvP001 100 mg
PvP001 300 mgDrug
PvP001 300 mg
PvP001 900 mgDrug
PvP001 900 mg
Maximum Feasible Dose (MFD) of PvP002Drug
Also called MFD of PvP002
MFD of PvP002
Maximum Tolerated Dose (MTD) of PvP001Drug
Maximum Tolerated Dose (MTD) of PvP001
MTD of PvP001 following 7 days of PPI treatmentDrug
Maximum Tolerated Dose (MTD) of PvP001 following 7 days of PPI (Proton Pump Inhibitor) treatment
PvP002 placeboOther
Placebo
PvP001 600 mgDrug
PvP001 600 mg
PvP003 placeboDrug
Placebo tablet orally.
PvP003Drug
PvP003 tablet orally.
PvP003 150 mgDrug
PvP003 150 mg

Study groups in NCT03701555
Study group	Role	What they receive
Part 1, Cohort 1A-1 to 1D-1 Healthy Participants	Experimental	A single dose of PvP001 placebo, PvP001 100 mg, PvP001 300 mg, or PvP001 900 mg will be administered in ascending order to healthy participants in Cohorts 1A-1, 1B-1, 1C-1, and 1D-1. Receives: Other: PvP001 placebo; Drug: PvP001 100 mg; Drug: PvP001 300 mg; Drug: PvP001 900 mg
Part 1, Cohort 1E-1 Healthy Participants	Experimental	A single dose of the maximum feasible dose (MFD) of PvP002 will then be administered to healthy participants in Cohort 1E-1. Receives: Drug: Maximum Feasible Dose (MFD) of PvP002
Part 1, Cohort 1A-2 - 1D-2 Celiac Disease (CeD)	Experimental	A single dose of PvP001 placebo, PvP001 100 mg, PvP001 300 mg, or PvP001 900 mg will be administered in ascending order to participants with CeD in Cohorts 1A-2, 1B-2, 1C-2, and 1D-2. Receives: Other: PvP001 placebo; Drug: PvP001 100 mg; Drug: PvP001 300 mg; Drug: PvP001 900 mg
Part 1, Cohort 1E-2 CeD	Experimental	A single dose of the MFD of PvP002 will then be administered to participants with CeD in Cohort 1E-2. Receives: Drug: Maximum Feasible Dose (MFD) of PvP002
Part 2, Cohort 2A - Cohort 2C Healthy Participants	Experimental	Participants will be blinded to the PvP001 dose (placebo or MTD of PvP001) and will also receive MTD of PvP001 following 7 days of PPI treatment. Receives: Other: PvP001 placebo; Drug: Maximum Tolerated Dose (MTD) of PvP001; Drug: MTD of PvP001 following 7 days of PPI treatment
Part 2, Cohort 2D Healthy Participants	Experimental	Participants will receive PvP001 placebo or MFD of PvP001. Receives: Other: PvP001 placebo; Drug: Maximum Tolerated Dose (MTD) of PvP001
Part 2, Cohort 2E Healthy Participants	Experimental	Participants will receive PvP002 placebo or MFD of PvP002. Receives: Drug: Maximum Feasible Dose (MFD) of PvP002; Other: PvP002 placebo
Part 2, Cohort 2F- Cohort 2H Healthy Participants	Experimental	Participants will receive the PvP001 placebo and either 300 mg or 600 mg of PvP001. Receives: Other: PvP001 placebo; Drug: PvP001 300 mg; Drug: PvP001 600 mg
Part 2, Cohort 2I and Cohort 2J Healthy Participants	Experimental	Participants will receive the PvP001 placebo and 900 mg of PvP001. Receives: Other: PvP001 placebo; Drug: PvP001 900 mg
Part 3, Cohorts 3A and 3B Healthy Participants	Experimental	Participants will receive single dose of PvP003 placebo and 600 mg of PvP003 with pretreatment buffer solution before a standardized 1 gm gluten-containing study meal. Receives: Drug: PvP003 placebo; Drug: PvP003
Part 3, Cohorts 3C and 3D Healthy Participants	Experimental	Participants will receive single dose of PvP003 placebo and 600 mg of PvP003 without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal. Receives: Drug: PvP003 placebo; Drug: PvP003
Part 3, Cohorts 3E and 3F Healthy Participants	Experimental	Participants will receive single dose of PvP003 placebo and 600 mg of PvP003 without pretreatment buffer solution after an approximately 50 milliliter (mL) portion of a standardized 1 gm gluten-containing study meal. Receives: Drug: PvP003 placebo; Drug: PvP003
Part 3, Cohorts 3G and 3H Healthy Participants	Experimental	Participants will receive single dose of PvP003 placebo and 600 mg of PvP003 without pretreatment buffer solution before a standardized gluten-free study meal followed approximately 30 minutes later by a standardized 1 gm gluten-containing study meal. Receives: Drug: PvP003 placebo; Drug: PvP003
Part 4, Cohorts 4A and 4B Healthy Participants	Experimental	Participants will receive multiple dose of PvP003 placebo and 600 mg of PvP003. Receives: Drug: PvP003 placebo; Drug: PvP003
Part 3, Cohorts 3I and 3J Healthy Participants	Experimental	Participants will receive single dose of PvP003 placebo and 150 mg of PvP003 without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal. Receives: Drug: PvP003 placebo; Drug: PvP003 150 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002
Measured: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7)
Part 4: Number of Participants Reporting One or More TEAEs for PvP003 After Multiple Doses
Measured: Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up to Day 28)
Part 1: Number of Participants Reporting One or More Treatment Emergent Serious Adverse Events (TESAEs) for PvP001 and PvP002
Measured: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7)
Part 4: Number of Participants Reporting One or More TESAEs for PvP003 600 mg After Multiple Doses
Measured: Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up to Day 28)
Part 2, Group 1, Cohort 2B: Median Percentage of Gluten Degradation by PvP001 in a Standardized 3 Gram (gm) Gluten-containing Study Meal After Administration of PvP001
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using Enzyme-Linked Immunosorbent Assay (ELISA) based on the monoclonal R5 and G12 antibodies.
Measured: Cohort Treatment Day
Part 2, Group 2, Cohort 2E: Median Percentage of Gluten Degradation by PvP002 in a Standardized 3 gm Gluten-containing Study Meal After Administration of PvP002
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Measured: Cohort Treatment Day
Part 2, Group 1, Cohort 2C: Median Percentage of Gluten Degradation by PvP001 in a Standardized 3 gm Gluten-containing Study Meal Following 7 Days of Standard Dose PPI Treatment
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Measured: Cohort Treatment Day
Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 20 Minutes After Administration of PvP001
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Measured: Cohort Treatment Day: at 20 minutes post-dose
Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 35 Minutes After Administration of PvP001
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Measured: Cohort Treatment Day: at 35 minutes post-dose
Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 65 Minutes After Administration of PvP001
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Measured: Cohort Treatment Day: at 65 minutes post-dose
Part 2, Group 3, Cohort 2J: Median Percentage of Gluten Degradation by PvP001 900 mg in a Standardized 6 gm Gluten-containing Study Meal at 20 Minutes After Administration of PvP001
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Measured: Cohort Treatment Day: at 20 minutes post-dose
Part 2, Group 3, Cohort 2J: Median Percentage of Gluten Degradation by PvP001 900 mg in a Standardized 6 gm Gluten-containing Study Meal at 35 Minutes After Administration of PvP001
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Measured: Cohort Treatment Day: at 35 minutes post-dose
Part 2, Group 3, Cohort 2J: Median Percentage of Gluten Degradation by PvP001 900 mg in a Standardized 6 gm Gluten-containing Study Meal at 65 Minutes After Administration of PvP001
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Measured: Cohort Treatment Day: at 65 minutes post-dose
Part 3, Groups 1 to 5, Cohorts 3B, 3D, 3F, 3H and 3J: Median Percentage of Gluten Degradation by PvP003 150 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 35 Minutes After Administration of PvP003
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Measured: Cohort Treatment Day: at 35 minutes
Part 3, Groups 1 to 5, Cohorts 3B, 3D, 3F, 3H and 3J: Median Percentage of Gluten Degradation by PvP003 150 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 65 Minutes After Administration of PvP003
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Measured: Cohort Treatment Day: at 65 minutes

Secondary outcomes (21)

Part 1 and Part 2, Cmax: Maximum Observed Plasma Concentration for PvP001 and PvP002
Measured: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose
Part 1 and Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for PvP001 and PvP002
Measured: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose
Part 1 and Part 2, T(1/2): Terminal Disposition Phase Half-life of PvP001 and PvP002
Measured: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose
Part 1 and Part 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for PvP001 and PvP002
Measured: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose
Part 1 and Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for PvP001 and PvP002
Measured: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose
Part 1 and Part 2: Number of Participants With Anti-drug Antibodies (ADA) for PvP001 and PvP002
Measured: At Day 14 and Day 28
Part 1: Maximum Tolerated Dose (MTD) of PvP001
MTD was defined as the maximum dose that was determined to be safe and tolerable for Part 1 (1B-1 and 1B-2, 1C-1 and 1C-2, 1D-1 and 1D-2) in healthy or CeD participants.
Measured: Cohort Treatment Day up to Day 7
Part 2: Number of Participants Reporting One or More TEAEs and TESAEs for PvP001 and PvP002
Measured: Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22)
Part 3: Number of Participants Reporting One or More TEAEs and TESAEs With PvP003 After a Single Dose
Measured: Cohort Treatment Day up to 5 days after final Cohort Treatment Day (up to Day 10)
Part 3, Cmax: Maximum Observed Plasma Concentration for PvP003 150 mg and 600 mg Single Dose
Measured: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose
Part 3, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for PvP003 150 mg and 600 mg Single Dose
Measured: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dose
Part 3, T(1/2): Terminal Disposition Phase Half-life of PvP003 150 mg and 600 mg Single Dose
Measured: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dose
Part 3, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for PvP003 150 mg and 600 mg Single Dose
Measured: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dose
Part 3, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for PvP003 150 mg and 600 mg Single Dose
Measured: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dose
Part 3: Number of Participants With ADA for PvP003 150 mg and 600 mg Single Dose
Measured: At Day 14 and Day 28
Part 4, Cmax: Maximum Observed Plasma Concentration for PvP003 600 mg Multiple Dose
Measured: Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose
Part 4, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for PvP003 600 mg Multiple Dose
Measured: Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose
Part 4, T(1/2): Terminal Disposition Phase Half-life of PvP003 600 mg Multiple Dose
Measured: Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose
Part 4, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for PvP003 600 mg Multiple Dose
Measured: Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose
Part 4, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for PvP003 600 mg Multiple Dose
Measured: Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose
Part 4: Number of Participants With ADA for PvP003 600 mg Multiple Dose
Measured: At Day 14 and Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jun 20182 Jul 2021

First posted10 Oct 2018
Study start19 Jun 2018
Primary completion31 Jan 2021
Study completion2 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: Sequential
Masking: Single blind
Who is masked: Participant
Enrolment: 139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03701555
Sponsor's protocol ID: PvP-102-01
Status last verified: Jun 2022
First submitted: 8 Oct 2018
Last updated: 4 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

Pultz IS, Hill M, Vitanza JM, Wolf C, Saaby L, Liu T, Winkle P, Leffler DA. Gluten Degradation, Pharmacokinetics, Safety, and Tolerability of TAK-062, an Engineered Enzyme to Treat Celiac Disease. Gastroenterology. 2021 Jul;161(1):81-93.e3. doi: 10.1053/j.gastro.2021.03.019. Epub 2021 Mar 17.
PubMed 33741317

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Four-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Gluten Degradation Activity of PvP001, PvP002, and PvP003 in Healthy Adult Volunteers and to Assess the Safety, Tolerability, and Pharmacokinetics of PvP001 and PvP002 in Adults With Celiac Disease
ClinicalTrials.gov ID: NCT03701555
Acronym / sponsor ID: PvP-102-01
Conditions: Digestive System Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 139 participants (actual)
Lead sponsor: Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 19 Jun 2018 (actual)
Primary completion: 31 Jan 2021 (actual)
Study completion: 2 Jul 2021 (actual)
First posted: 10 Oct 2018 (actual)
Results: Posted 4 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Following completion of all screening procedures, eligible participants will be enrolled in the study.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind (participant)
Number of arms: 15

Arm	Type	Receives
Part 1, Cohort 1A-1 to 1D-1 Healthy Participants	Experimental	Other: PvP001 placebo, Drug: PvP001 100 mg, Drug: PvP001 300 mg, Drug: PvP001 900 mgA single dose of PvP001 placebo, PvP001 100 mg, PvP001 300 mg, or PvP001 900 mg will be administered in ascending order to healthy participants in Cohorts 1A-1, 1B-1, 1C-1, and 1D-1.
Part 1, Cohort 1E-1 Healthy Participants	Experimental	Drug: Maximum Feasible Dose (MFD) of PvP002A single dose of the maximum feasible dose (MFD) of PvP002 will then be administered to healthy participants in Cohort 1E-1.
Part 1, Cohort 1A-2 - 1D-2 Celiac Disease (CeD)	Experimental	Other: PvP001 placebo, Drug: PvP001 100 mg, Drug: PvP001 300 mg, Drug: PvP001 900 mgA single dose of PvP001 placebo, PvP001 100 mg, PvP001 300 mg, or PvP001 900 mg will be administered in ascending order to participants with CeD in Cohorts 1A-2, 1B-2, 1C-2, and 1D-2.
Part 1, Cohort 1E-2 CeD	Experimental	Drug: Maximum Feasible Dose (MFD) of PvP002A single dose of the MFD of PvP002 will then be administered to participants with CeD in Cohort 1E-2.
Part 2, Cohort 2A - Cohort 2C Healthy Participants	Experimental	Other: PvP001 placebo, Drug: Maximum Tolerated Dose (MTD) of PvP001, Drug: MTD of PvP001 following 7 days of PPI treatmentParticipants will be blinded to the PvP001 dose (placebo or MTD of PvP001) and will also receive MTD of PvP001 following 7 days of PPI treatment.
Part 2, Cohort 2D Healthy Participants	Experimental	Other: PvP001 placebo, Drug: Maximum Tolerated Dose (MTD) of PvP001Participants will receive PvP001 placebo or MFD of PvP001.
Part 2, Cohort 2E Healthy Participants	Experimental	Drug: Maximum Feasible Dose (MFD) of PvP002, Other: PvP002 placeboParticipants will receive PvP002 placebo or MFD of PvP002.
Part 2, Cohort 2F- Cohort 2H Healthy Participants	Experimental	Other: PvP001 placebo, Drug: PvP001 300 mg, Drug: PvP001 600 mgParticipants will receive the PvP001 placebo and either 300 mg or 600 mg of PvP001.
Part 2, Cohort 2I and Cohort 2J Healthy Participants	Experimental	Other: PvP001 placebo, Drug: PvP001 900 mgParticipants will receive the PvP001 placebo and 900 mg of PvP001.
Part 3, Cohorts 3A and 3B Healthy Participants	Experimental	Drug: PvP003 placebo, Drug: PvP003Participants will receive single dose of PvP003 placebo and 600 mg of PvP003 with pretreatment buffer solution before a standardized 1 gm gluten-containing study meal.
Part 3, Cohorts 3C and 3D Healthy Participants	Experimental	Drug: PvP003 placebo, Drug: PvP003Participants will receive single dose of PvP003 placebo and 600 mg of PvP003 without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal.
Part 3, Cohorts 3E and 3F Healthy Participants	Experimental	Drug: PvP003 placebo, Drug: PvP003Participants will receive single dose of PvP003 placebo and 600 mg of PvP003 without pretreatment buffer solution after an approximately 50 milliliter (mL) portion of a standardized 1 gm gluten-containing study meal.
Part 3, Cohorts 3G and 3H Healthy Participants	Experimental	Drug: PvP003 placebo, Drug: PvP003Participants will receive single dose of PvP003 placebo and 600 mg of PvP003 without pretreatment buffer solution before a standardized gluten-free study meal followed approximately 30 minutes later by a standardized 1 gm gluten-containing study meal.
Part 4, Cohorts 4A and 4B Healthy Participants	Experimental	Drug: PvP003 placebo, Drug: PvP003Participants will receive multiple dose of PvP003 placebo and 600 mg of PvP003.
Part 3, Cohorts 3I and 3J Healthy Participants	Experimental	Drug: PvP003 placebo, Drug: PvP003 150 mgParticipants will receive single dose of PvP003 placebo and 150 mg of PvP003 without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (20 listed)

Part 1, Part 2, Part 3 and Part 4
Male or female age 18- 64 years, inclusive
No relevant gastrointestinal symptoms
Able to abstain from alcohol for 72 hours prior to the Screening Visit; for 72 hours prior to and after the Cohort Treatment Day (Part 1, Part 2, and Part 3); for 72 hours prior to the Safety Visit (Part 2 and Part 3); and for 72 hours prior to Day 1 of the first Cohort Treatment Period through the Safety Visit (Part 4).
A female participant must have a negative pregnancy test at Screening and on Cohort Treatment Day -1 (Part 1, Part 2, and Part 3) or a negative pregnancy test at Screening and on Day -1 of each Cohort Treatment Period (Part 4), and must agree to continue acceptable birth control measures (example, abstinence, a stable hormonal contraceptive, double-barrier method, or vasectomy in partner) from the Screening Visit through the 28 ± 2 days. Follow Up ADA Blood Sampling Visit

Key exclusion criteria (8 listed)

Part 1, Part 2, Part 3, and Part 4
Current symptoms or signs of illness
Chronic viral infection or immunodeficiency condition
Any female who is pregnant, planning to become pregnant during the study, or breast-feeding; any male who is planning to father a child during the study
Receipt (or planned receipt) of another investigational medication within 4 weeks prior to the Screening Visit through the duration of the study

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
PvP001 placeboplacebo	Other	Part 1, Cohort 1A-1 to 1D-1 Healthy Participants, Part 1, Cohort 1A-2 - 1D-2 Celiac Disease (CeD), Part 2, Cohort 2A - Cohort 2C Healthy Participants, Part 2, Cohort 2D Healthy Participants, Part 2, Cohort 2F- Cohort 2H Healthy Participants, Part 2, Cohort 2I and Cohort 2J Healthy Participants
PvP001 100 mgPvP001 100 mg	Drug	Part 1, Cohort 1A-1 to 1D-1 Healthy Participants, Part 1, Cohort 1A-2 - 1D-2 Celiac Disease (CeD)
PvP001 300 mgPvP001 300 mg	Drug	Part 1, Cohort 1A-1 to 1D-1 Healthy Participants, Part 1, Cohort 1A-2 - 1D-2 Celiac Disease (CeD), Part 2, Cohort 2F- Cohort 2H Healthy Participants
PvP001 900 mgPvP001 900 mg	Drug	Part 1, Cohort 1A-1 to 1D-1 Healthy Participants, Part 1, Cohort 1A-2 - 1D-2 Celiac Disease (CeD), Part 2, Cohort 2I and Cohort 2J Healthy Participants
Maximum Feasible Dose (MFD) of PvP002Also: MFD of PvP002MFD of PvP002	Drug	Part 1, Cohort 1E-1 Healthy Participants, Part 1, Cohort 1E-2 CeD, Part 2, Cohort 2E Healthy Participants
Maximum Tolerated Dose (MTD) of PvP001Maximum Tolerated Dose (MTD) of PvP001	Drug	Part 2, Cohort 2A - Cohort 2C Healthy Participants, Part 2, Cohort 2D Healthy Participants
MTD of PvP001 following 7 days of PPI treatmentMaximum Tolerated Dose (MTD) of PvP001 following 7 days of PPI (Proton Pump Inhibitor) treatment	Drug	Part 2, Cohort 2A - Cohort 2C Healthy Participants
PvP002 placeboPlacebo	Other	Part 2, Cohort 2E Healthy Participants
PvP001 600 mgPvP001 600 mg	Drug	Part 2, Cohort 2F- Cohort 2H Healthy Participants
PvP003 placeboPlacebo tablet orally.	Drug	Part 3, Cohorts 3A and 3B Healthy Participants, Part 3, Cohorts 3C and 3D Healthy Participants, Part 3, Cohorts 3E and 3F Healthy Participants, Part 3, Cohorts 3G and 3H Healthy Participants, Part 3, Cohorts 3I and 3J Healthy Participants, Part 4, Cohorts 4A and 4B Healthy Participants
PvP003PvP003 tablet orally.	Drug	Part 3, Cohorts 3A and 3B Healthy Participants, Part 3, Cohorts 3C and 3D Healthy Participants, Part 3, Cohorts 3E and 3F Healthy Participants, Part 3, Cohorts 3G and 3H Healthy Participants, Part 4, Cohorts 4A and 4B Healthy Participants
PvP003 150 mgPvP003 150 mg	Drug	Part 3, Cohorts 3I and 3J Healthy Participants

Primary outcome

Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002
Time frame: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7)
Part 4: Number of Participants Reporting One or More TEAEs for PvP003 After Multiple Doses
Time frame: Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up to Day 28)
Part 1: Number of Participants Reporting One or More Treatment Emergent Serious Adverse Events (TESAEs) for PvP001 and PvP002
Time frame: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7)
Part 4: Number of Participants Reporting One or More TESAEs for PvP003 600 mg After Multiple Doses
Time frame: Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up to Day 28)
Part 2, Group 1, Cohort 2B: Median Percentage of Gluten Degradation by PvP001 in a Standardized 3 Gram (gm) Gluten-containing Study Meal After Administration of PvP001
Time frame: Cohort Treatment Day
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using Enzyme-Linked Immunosorbent Assay (ELISA) based on the monoclonal R5 and G12 antibodies.
Part 2, Group 2, Cohort 2E: Median Percentage of Gluten Degradation by PvP002 in a Standardized 3 gm Gluten-containing Study Meal After Administration of PvP002
Time frame: Cohort Treatment Day
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Part 2, Group 1, Cohort 2C: Median Percentage of Gluten Degradation by PvP001 in a Standardized 3 gm Gluten-containing Study Meal Following 7 Days of Standard Dose PPI Treatment
Time frame: Cohort Treatment Day
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 20 Minutes After Administration of PvP001
Time frame: Cohort Treatment Day: at 20 minutes post-dose
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 35 Minutes After Administration of PvP001
Time frame: Cohort Treatment Day: at 35 minutes post-dose
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 65 Minutes After Administration of PvP001
Time frame: Cohort Treatment Day: at 65 minutes post-dose
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Part 2, Group 3, Cohort 2J: Median Percentage of Gluten Degradation by PvP001 900 mg in a Standardized 6 gm Gluten-containing Study Meal at 20 Minutes After Administration of PvP001
Time frame: Cohort Treatment Day: at 20 minutes post-dose
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Part 2, Group 3, Cohort 2J: Median Percentage of Gluten Degradation by PvP001 900 mg in a Standardized 6 gm Gluten-containing Study Meal at 35 Minutes After Administration of PvP001
Time frame: Cohort Treatment Day: at 35 minutes post-dose
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Part 2, Group 3, Cohort 2J: Median Percentage of Gluten Degradation by PvP001 900 mg in a Standardized 6 gm Gluten-containing Study Meal at 65 Minutes After Administration of PvP001
Time frame: Cohort Treatment Day: at 65 minutes post-dose
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Part 3, Groups 1 to 5, Cohorts 3B, 3D, 3F, 3H and 3J: Median Percentage of Gluten Degradation by PvP003 150 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 35 Minutes After Administration of PvP003
Time frame: Cohort Treatment Day: at 35 minutes
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Part 3, Groups 1 to 5, Cohorts 3B, 3D, 3F, 3H and 3J: Median Percentage of Gluten Degradation by PvP003 150 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 65 Minutes After Administration of PvP003
Time frame: Cohort Treatment Day: at 65 minutes
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.

21 secondary outcomes

Part 1 and Part 2, Cmax: Maximum Observed Plasma Concentration for PvP001 and PvP002
Time frame: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose
Part 1 and Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for PvP001 and PvP002
Time frame: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose
Part 1 and Part 2, T(1/2): Terminal Disposition Phase Half-life of PvP001 and PvP002
Time frame: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose
Part 1 and Part 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for PvP001 and PvP002
Time frame: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose
Part 1 and Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for PvP001 and PvP002
Time frame: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose
Part 1 and Part 2: Number of Participants With Anti-drug Antibodies (ADA) for PvP001 and PvP002
Time frame: At Day 14 and Day 28
Part 1: Maximum Tolerated Dose (MTD) of PvP001
Time frame: Cohort Treatment Day up to Day 7
Part 2: Number of Participants Reporting One or More TEAEs and TESAEs for PvP001 and PvP002
Time frame: Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22)
Part 3: Number of Participants Reporting One or More TEAEs and TESAEs With PvP003 After a Single Dose
Time frame: Cohort Treatment Day up to 5 days after final Cohort Treatment Day (up to Day 10)
Part 3, Cmax: Maximum Observed Plasma Concentration for PvP003 150 mg and 600 mg Single Dose
Time frame: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose
Part 3, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for PvP003 150 mg and 600 mg Single Dose
Time frame: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dose
Part 3, T(1/2): Terminal Disposition Phase Half-life of PvP003 150 mg and 600 mg Single Dose
Time frame: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dose
Part 3, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for PvP003 150 mg and 600 mg Single Dose
Time frame: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dose
Part 3, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for PvP003 150 mg and 600 mg Single Dose
Time frame: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dose
Part 3: Number of Participants With ADA for PvP003 150 mg and 600 mg Single Dose
Time frame: At Day 14 and Day 28
Part 4, Cmax: Maximum Observed Plasma Concentration for PvP003 600 mg Multiple Dose
Time frame: Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose
Part 4, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for PvP003 600 mg Multiple Dose
Time frame: Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose
Part 4, T(1/2): Terminal Disposition Phase Half-life of PvP003 600 mg Multiple Dose
Time frame: Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose
Part 4, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for PvP003 600 mg Multiple Dose
Time frame: Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose
Part 4, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for PvP003 600 mg Multiple Dose
Time frame: Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose
Part 4: Number of Participants With ADA for PvP003 600 mg Multiple Dose
Time frame: At Day 14 and Day 28

Results and safety

Results posted to the registry on 4 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1, (1A-1): PvP001 Placebo	3	3
Part 1, (1B-1): PvP001 100 mg	3	3
Part 1, (1C-1): PvP001 300 mg	3	3
Part 1, (1D-1): PvP001 900 mg	3	3
Part 1, (1E-1): PvP002 600 mg	3	3
Part 1, (1A-2): PvP001 Placebo	3	3
Part 1, (1B-2): PvP001 100 mg	3	3
Part 1, (1C-2): PvP001 300 mg	3	3
Part 1, (1D-2): PvP001 900 mg	3	3
Part 1, (1E-2): PvP002 600 mg	1	1
Part 2, Group 1: PvP001 Placebo (2A) + PvP001 900 mg (2B) + PvP001 900 mg With PPI (2C)	0	0
Part 2, Group 1: PvP001 Placebo (2A) + PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B)	0	0
Part 2, Group 1: PvP001 900 mg (2B) + PvP001 Placebo (2A) + PvP001 900 mg With PPI (2C)	0	0
Part 2, Group 1: PvP001 900 mg (2B) + PvP001 900 mg With PPI (2C) + PvP001 Placebo (2A)	0	0
Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 Placebo (2A) + PvP001 900 mg (2B)	0	0
Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)	0	0
Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)	0	0
Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)	0	0
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)	0	0
Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)	0	0
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)	0	0
Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)	0	0
Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)	0	0
Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)	0	0
Part 3, Group 1: PvP003 Placebo (3A) + PvP003 600 mg (3B)	0	0
Part 3, Group 1: PvP003 600 mg (3B) + PvP003 Placebo (3A)	0	0
Part 3, Group 2: PvP003 Placebo (3C) + PvP003 600 mg (3D)	0	0
Part 3, Group 2: PvP003 600 mg (3D) + PvP003 Placebo (3C)	0	0
Part 3, Group 3: PvP003 Placebo (3E) + PvP003 600 mg (3F)	0	0
Part 3, Group 3: PvP003 600 mg (3F) + PvP003 Placebo (3E)	0	0
Part 3, Group 4: PvP003 Placebo (3G) + PvP003 600 mg (3H)	0	0
Part 3, Group 4: PvP003 600 mg (3H) + PvP003 Placebo (3G)	0	0
Part 3, Group 5: PvP003 Placebo (3I) + PvP003 150 mg (3J)	0	0
Part 3, Group 5: PvP003 150 mg (3J) + PvP003 Placebo (3I)	0	0
Part 4: PvP003 Placebo, TID (4A) + PvP003 600 mg, TID (4B)	0	0
Part 4: PvP003 600 mg, TID (4B) + PvP003 Placebo, TID (4A)	0	0

Primary outcome: Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002

Time frame: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7). Count of participants. Unit: Participants

Measure	Part 1, (1A-1): PvP001 Placebo n = 3	Part 1, (1B-1): PvP001 100 mg n = 3	Part 1, (1C-1): PvP001 300 mg n = 3	Part 1, (1D-1): PvP001 900 mg n = 3	Part 1, (1E-1): PvP002 600 mg n = 3	Part 1, (1A-2): PvP001 Placebo n = 3	Part 1, (1B-2): PvP001 100 mg n = 3	Part 1, (1C-2): PvP001 300 mg n = 3	Part 1, (1D-2): PvP001 900 mg n = 3	Part 1, (1E-2): PvP002 600 mg n = 1
Value	0	0	0	0	0	3	0	2	1	1

Population analysed: Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed only for Part 1 of the study.

Primary outcome: Part 4: Number of Participants Reporting One or More TEAEs for PvP003 After Multiple Doses

Time frame: Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up to Day 28). Count of participants. Unit: Participants

Measure	Part 4: PvP003 Placebo, TID (4A) n = 6	Part 4: PvP003 600 mg, TID (4B) n = 6
Value	0	0

Population analysed: Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed only for Part 4 of the study.

Primary outcome: Part 1: Number of Participants Reporting One or More Treatment Emergent Serious Adverse Events (TESAEs) for PvP001 and PvP002

Time frame: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7). Count of participants. Unit: Participants

Measure	Part 1, (1A-1): PvP001 Placebo n = 3	Part 1, (1B-1): PvP001 100 mg n = 3	Part 1, (1C-1): PvP001 300 mg n = 3	Part 1, (1D-1): PvP001 900 mg n = 3	Part 1, (1E-1): PvP002 600 mg n = 3	Part 1, (1A-2): PvP001 Placebo n = 3	Part 1, (1B-2): PvP001 100 mg n = 3	Part 1, (1C-2): PvP001 300 mg n = 3	Part 1, (1D-2): PvP001 900 mg n = 3	Part 1, (1E-2): PvP002 600 mg n = 1
Value	0	0	0	0	0	0	0	0	0	0

Population analysed: Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed only for Part 1 of the study.

Primary outcome: Part 4: Number of Participants Reporting One or More TESAEs for PvP003 600 mg After Multiple Doses

Time frame: Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up to Day 28). Count of participants. Unit: Participants

Measure	Part 4: PvP003 Placebo, TID (4A) n = 6	Part 4: PvP003 600 mg, TID (4B) n = 6
Value	0	0

Population analysed: Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed only for Part 4 of the study.

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1, (1A-1): PvP001 Placebo	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Part 1, (1B-1): PvP001 100 mg	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Part 1, (1C-1): PvP001 300 mg	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Part 1, (1D-1): PvP001 900 mg	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Part 1, (1E-1): PvP002 600 mg	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Part 1, (1A-2): PvP001 Placebo	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part 1, (1B-2): PvP001 100 mg	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Part 1, (1C-2): PvP001 300 mg	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Part 1, (1D-2): PvP001 900 mg	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Part 1, (1E-2): PvP002 600 mg	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Part 2, Group 1: PvP001 Placebo (2A)	0 of 13 (0%)	1 of 13 (7.7%)	0 of 13
Part 2, Group 1: PvP001 900 mg (2B)	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Part 2, Group 1: PvP001 900 mg With PPI (2C)	0 of 13 (0%)	2 of 13 (15.4%)	0 of 13
Part 2, Group 2: PvP002 Comparator (2D)	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Part 2, Group 2: PvP002 600 mg (2E)	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Part 2, Group 3: PvP001 Placebo (2F and 2I)	0 of 24 (0%)	1 of 24 (4.2%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33741317Pultz IS, Hill M, Vitanza JM, Wolf C, Saaby L, Liu T, Winkle P, Leffler DA. Gluten Degradation, Pharmacokinetics, Safety, and Tolerability of TAK-062, an Engineered Enzyme to Treat Celiac Disease. Gastroenterology. 2021 Jul;161(1):81-93.e3. doi: 10.1053/j.gastro.2021.03.019. Epub 2021 Mar 17.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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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.

Study Director study director

Takeda

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 PvP001 100 mg, PvP001 300 mg and PvP001 900 mg in people with Digestive System Disease, run by Millennium Pharmaceuticals, Inc. 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 20 inclusion and 8 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: finished, as of the sponsor's last update on 4 Apr 2023. 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?

Yes. Results are posted in the registry (first posted 4 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002 (time frame: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03701555, which also lists 1 linked publication.

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 4 Apr 2023.