Assess the Safety, Tolerability, Pharmacokinetics (PK), and Gluten Degradation Activity of PvP001, PvP002, and PvP003 in Healthy Adult Volunteers and to Assess the Safety, Tolerability, and PK of PvP001 and PvP002 in Adults With Celiac Disease (CeD)

Study Purpose

The purpose of the study is to determine the safety and tolerability of single doses of PvP001 and PvP002, in healthy volunteers and participants with CeD in Part 1, to evaluate the ability of PvP001 and PvP002 to degrade gluten in healthy volunteers and to determine the effect of standard dose proton pump inhibitor (PPI) pretreatment on the ability of PvP001 to degrade gluten in healthy volunteers in Part 2, to evaluate the ability of PvP003 to degrade gluten in healthy volunteers in Part 3, and to determine the safety and tolerability of multiple doses of PvP003 600 milligram (mg), in healthy volunteers in Part 4.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 64 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Part 1, Part 2, Part 3 and Part 4 1. Male or female age 18- 64 years, inclusive 2. No relevant gastrointestinal symptoms 3. 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). 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 Anti-Drug Antibody Blood Sampling Visit 5. A male participant must agree to 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 6. Able to read and understand English 7. Able to provide written informed consent Additional Inclusion Criteria for Part 1, Part 2, Part 3, and Part 4 Healthy Adult Volunteers 8. No use of over-the-counter or prescription medication, except for birth control medications for the duration of the study 9. No history of gastrointestinal diseases or disorders 10. No history of intolerance, sensitivity, or reactions to gluten or any other food or food ingredient 11. 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 12. Documented history of Celiac Disease in medical records 13. Maintaining a gluten-free diet for ≥6 months 14. 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. 15. No history of gastrointestinal diseases or disorders, other than Celiac Disease 16. No history of intolerance, hypersensitivity, or reaction to any food or food ingredient 17. Able to continue a gluten-free diet for the duration of the study

Exclusion Criteria:

Part 1, Part 2, Part 3, and Part 4 1. Current symptoms or signs of illness 2. Chronic viral infection or immunodeficiency condition 3. 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 4. Receipt (or planned receipt) of another investigational medication within 4 weeks prior to the Screening Visit through the duration of the study 5. 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 6. 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 7. 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03701555
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Takeda
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Peter Winkle, MD
Principal Investigator Affiliation Anaheim Clinical Trials
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Digestive System Disease
Additional Details

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.

Arms & Interventions

Arms

Experimental: Part 1, Cohort 1A-1 to 1D-1 Healthy Participants

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.

Experimental: Part 1, Cohort 1E-1 Healthy Participants

A single dose of the maximum feasible dose (MFD) of PvP002 will then be administered to healthy participants in Cohort 1E-1.

Experimental: Part 1, Cohort 1A-2 - 1D-2 Celiac Disease (CeD)

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.

Experimental: Part 1, Cohort 1E-2 Celiac Disease (CeD)

A single dose of the MFD of PvP002 will then be administered to participants with CeD in Cohort 1E-2.

Experimental: Part 2, Cohort 2A - Cohort 2C Healthy Participants

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.

Experimental: Part 2, Cohort 2D Healthy Participants

Participants will receive PvP001 placebo or MFD of PvP001.

Experimental: Part 2, Cohort 2E Healthy Participants

Participants will receive PvP002 placebo or MFD of PvP002.

Experimental: Part 2, Cohort 2F- Cohort 2H Healthy Participants

Participants will receive the PvP001 placebo and either 300 mg or 600 mg of PvP001.

Experimental: Part 2, Cohort 2I and Cohort 2J Healthy Participants

Participants will receive the PvP001 placebo and 900 mg of PvP001.

Experimental: Part 3, Cohorts 3A and 3B Healthy Participants

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.

Experimental: Part 3, Cohorts 3C and 3D Healthy Participants

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.

Experimental: Part 3, Cohorts 3E and 3F Healthy Participants

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.

Experimental: Part 3, Cohorts 3G and 3H Healthy Participants

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.

Experimental: Part 4, Cohorts 4A and 4B Healthy Participants

Participants will receive multiple dose of PvP003 placebo and 600 mg of PvP003.

Experimental: Part 3, Cohorts 3I and 3J Healthy Participants

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.

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

Maximum Feasible Dose (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

Contact a Trial Team

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Anaheim Clinical Trials, Anaheim, California

Status

Recruiting

Address

Anaheim Clinical Trials

Anaheim, California, 92801

Site Contact

Peter Winkle, MD

pwinkle@agmg.com

714-774-7777

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