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

Summary

It is hoped that different forms of the same medicine, called PVP001, PVP002, and PVP003, will help people with celiac disease. Both healthy adults and adults with celiac disease will take part in this study.

There are many main aims of the study.

* To check if participants have side effects from different forms of the study medicine. These forms are called PVP001 (liquid in a cup), PVP002 capsule, and PVP003 tablet.
* To check how well PVP003 breaks down gluten.
* To check how much PVP003 participants can take without getting side effects from it.

The study is in 4 parts. At the start of each part of the study, the study doctor will check to determine who can take part at the first study visit. Different groups of participants will be in different parts of the study.

In all parts of the study, some participants will take 1 of the 3 forms of study medicine. Others will take a placebo. In this study, a placebo will look like the form of study medicine but will not have any medicine in it. This means that a placebo can either look like PVP001 liquid in a cup, the PVP002 tablet, or the PVP003 tablet.

In Part 1, different small groups of participants will take lower to higher doses of PVP001 or PVP002 or a placebo. This is to work out the best dose of study medicine to take in other parts of the study. After treatment, participants will regularly visit the clinic to check that they have no problems with their treatment, including any side effects from their treatment.

In Part 2, different small groups will take different doses of PVP001 or PVP002 or a placebo, either with or without a meal that has different amounts of gluten in it. This is to check if PVP001 or PVP002 has broken down gluten in the body. Participants will visit the clinic after treatment to check how much gluten has been broken down in the body.

In Part 3, different small groups will take different doses of PVP003 or a placebo, either with or without a meal that has gluten in it. This is to check 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.

Conditions

• Digestive System Disease

Interventions

OTHER

PvP001 placebo

placebo

DRUG

PvP001 100 mg

PvP001 100 mg

DRUG

PvP001 300 mg

PvP001 300 mg

DRUG

PvP001 900 mg

PvP001 900 mg

DRUG

Maximum Feasible Dose (MFD) of PvP002

MFD of PvP002

DRUG

Maximum Tolerated Dose (MTD) of PvP001

Maximum Tolerated Dose (MTD) of PvP001

DRUG

MTD of PvP001 following 7 days of PPI treatment

Maximum Tolerated Dose (MTD) of PvP001 following 7 days of PPI (Proton Pump Inhibitor) treatment

OTHER

PvP002 placebo

Placebo

DRUG

PvP001 600 mg

PvP001 600 mg

DRUG

PvP003 placebo

Placebo tablet orally.

DRUG

PvP003

PvP003 tablet orally.

DRUG

PvP003 150 mg

PvP003 150 mg

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.

  lead INDUSTRY

Principal Investigators

• Study Director · Takeda

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-06-19

Primary Completion

2021-01-31

Completion

2021-07-02

FDA Drug

Yes

Countries

• United States

Study Locations