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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
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| 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. |
|
| Part 2, Cohort 2A - Cohort 2C Healthy Participants |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PvP001 placebo | Other | placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002 | 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 | 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 | 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 | 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. | 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. | Cohort Treatment Day |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and Part 2, Cmax: Maximum Observed Plasma Concentration for PvP001 and PvP002 | 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 |
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Inclusion Criteria:
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
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
Exclusion Criteria:
Part 1, Part 2, Part 3, and Part 4
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33741317 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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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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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Healthy participants and participants with Celiac Disease (CeD) were enrolled in this 4-part study. In Part 1, healthy participants and participants with CeD were enrolled and in Parts 2, 3 and 4 only healthy participants were enrolled to receive PVP001 (TAK-062 liquid), PVP002 (TAK-062 capsule), and PVP003 (TAK-062 tablet) formulation or matching-placebo.
Participants took part in this study at 1 investigative site in the United States from 19 June 2018 to 02 July 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1, (1A-1): PvP001 Placebo | PvP001 (TAK-062 liquid formulation) placebo-matching liquid, orally, single dose on Cohort Treatment Day in healthy participants. |
| FG001 | Part 1, (1B-1): PvP001 100 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 (Day 1) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 15, 2020 | Jun 21, 2022 |
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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. |
|
| Part 2, Cohort 2D Healthy Participants | Experimental | Participants will receive PvP001 placebo or MFD of PvP001. |
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| Part 2, Cohort 2E Healthy Participants | Experimental | Participants will receive PvP002 placebo or MFD of PvP002. |
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| Part 2, Cohort 2F- Cohort 2H Healthy Participants | Experimental | Participants will receive the PvP001 placebo and either 300 mg or 600 mg of PvP001. |
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| Part 2, Cohort 2I and Cohort 2J Healthy Participants | Experimental | Participants will receive the PvP001 placebo and 900 mg of PvP001. |
|
| 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. |
|
| 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. |
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| 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. |
|
| 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. |
|
| Part 4, Cohorts 4A and 4B Healthy Participants | Experimental | Participants will receive multiple dose of PvP003 placebo and 600 mg of 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. |
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| PvP001 100 mg | Drug | PvP001 100 mg |
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| PvP001 300 mg | Drug | PvP001 300 mg |
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| PvP001 900 mg | Drug | PvP001 900 mg |
|
| Maximum Feasible Dose (MFD) of PvP002 | Drug | MFD of PvP002 |
|
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| Maximum Tolerated Dose (MTD) of PvP001 | Drug | Maximum Tolerated Dose (MTD) of PvP001 |
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| MTD of PvP001 following 7 days of PPI treatment | Drug | Maximum Tolerated Dose (MTD) of PvP001 following 7 days of PPI (Proton Pump Inhibitor) treatment |
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| PvP002 placebo | Other | Placebo |
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| PvP001 600 mg | Drug | PvP001 600 mg |
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| PvP003 placebo | Drug | Placebo tablet orally. |
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| PvP003 | Drug | PvP003 tablet orally. |
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| PvP003 150 mg | Drug | PvP003 150 mg |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Cohort Treatment Day: at 65 minutes |
| 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 | 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 | 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 | 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 | 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. | Cohort Treatment Day up to Day 7 |
| Part 2: Number of Participants Reporting One or More TEAEs and TESAEs for PvP001 and PvP002 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | At Day 14 and Day 28 |
| Part 4, Cmax: Maximum Observed Plasma Concentration for PvP003 600 mg Multiple Dose | 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 | 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 | 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 | 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 | 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 | At Day 14 and Day 28 |
PvP001 (TAK-062 liquid formulation) 100 milligram (mg), orally, single dose on Cohort Treatment Day in healthy participants.
| FG002 | Part 1, (1C-1): PvP001 300 mg | PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in healthy participants. |
| FG003 | Part 1, (1D-1): PvP001 900 mg | PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in healthy participants. |
| FG004 | Part 1, (1E-1): PvP002 600 mg | PvP002 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in healthy participants. |
| FG005 | Part 1, (1A-2): PvP001 Placebo | PvP001 (TAK-062 liquid formulation) placebo-matching liquid, orally, single dose on Cohort Treatment Day in CeD participants. |
| FG006 | Part 1, (1B-2): PvP001 100 mg | PvP001 (TAK-062 liquid formulation) 100 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| FG007 | Part 1, (1C-2): PvP001 300 mg | PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| FG008 | Part 1, (1D-2): PvP001 900 mg | PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| FG009 | Part 1, (1E-2): PvP002 600 mg | PvP002 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| FG010 | Part 2, Group 1: PvP001 Placebo (2A) + PvP001 900 mg (2B) + PvP001 900 mg With PPI (2C) | PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 900 mg following 7 days of proton pump inhibitor (PPI) treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| FG011 | Part 2, Group 1: PvP001 Placebo (2A) + PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) | PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C further followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| FG012 | Part 2, Group 1: PvP001 900 mg (2B) + PvP001 Placebo (2A) + PvP001 900 mg With PPI (2C) | PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, further followed by PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| FG013 | Part 2, Group 1: PvP001 900 mg (2B) + PvP001 900 mg With PPI (2C) + PvP001 Placebo (2A) | PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, further followed by PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| FG014 | Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 Placebo (2A) + PvP001 900 mg (2B) | PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, further followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| FG015 | Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A) | PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| FG016 | Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E) | PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| FG017 | Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D) | PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| FG018 | Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G) | PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| FG019 | Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F) | PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| FG020 | Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H) | PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| FG021 | Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F) | PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| FG022 | Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J) | PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| FG023 | Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I) | PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| FG024 | Part 3, Group 1: PvP003 Placebo (3A) + PvP003 600 mg (3B) | PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3A) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3A, followed by PvP003 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| FG025 | Part 3, Group 1: PvP003 600 mg (3B) + PvP003 Placebo (3A) | PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B, followed by PvP003 placebo-matching tablet (3A) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3A in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| FG026 | Part 3, Group 2: PvP003 Placebo (3C) + PvP003 600 mg (3D) | PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3C) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3C, followed by PvP003 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| FG027 | Part 3, Group 2: PvP003 600 mg (3D) + PvP003 Placebo (3C) | PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D, followed by PvP003 placebo-matching tablet (3C) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3C in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| FG028 | Part 3, Group 3: PvP003 Placebo (3E) + PvP003 600 mg (3F) | PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3E) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003 orally, single dose on Cohort Treatment Day of Cohort 3E, followed by PvP003 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003 orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| FG029 | Part 3, Group 3: PvP003 600 mg (3F) + PvP003 Placebo (3E) | PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003 orally, single dose on Cohort Treatment Day of Cohort 3F, followed by PvP003 placebo-matching tablet (3E) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3E, in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| FG030 | Part 3, Group 4: PvP003 Placebo (3G) + PvP003 600 mg (3H) | PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3G) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3G, followed by PvP003 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| FG031 | Part 3, Group 4: PvP003 600 mg (3H) + PvP003 Placebo (3G) | PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H, followed by PvP003 placebo-matching tablet (3G) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3G, in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| FG032 | Part 3, Group 5: PvP003 Placebo (3I) + PvP003 150 mg (3J) | PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3I) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3I, followed by PvP003 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| FG033 | Part 3, Group 5: PvP003 150 mg (3J) + PvP003 Placebo (3I) | PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J, followed by PvP003 placebo-matching tablet (3I) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3I in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| FG034 | Part 4: PvP003 Placebo, TID (4A) + PvP003 600 mg, TID (4B) | PvP003 (TAK-062 tablet formulation) placebo-matching tablet, administered as two tablets of PvP003 placebo, orally, thrice a day (TID) on Treatment Days 1 to 5 (4A) of Cohort Treatment Period 1, followed by PvP003 600 mg administered as two tablets of PvP003 300 mg, orally, TID on Treatment Days 1 to 5 (4B) of Cohort Treatment Period 2 in healthy participants. There was a washout period of 3 days between the two Cohort Treatment Periods. |
| FG035 | Part 4: PvP003 600 mg, TID (4B) + PvP003 Placebo, TID (4A) | PvP003 (TAK-062 tablet formulation) 600 mg, administered as two tablets of PvP003 300 mg, orally, TID on Treatment Days 1 to 5 (4B) of Cohort Treatment Period 1, followed by PvP003 placebo-matching tablet, administered as two tablets of PvP003 placebo, orally, TID on Treatment Days 1 to 5 (4A) of Cohort Treatment Period 2 in healthy participants. There was a washout period of 3 days between the two Cohort Treatment Periods. |
| COMPLETED |
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| NOT COMPLETED |
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| Part 2 (Day 1) |
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| Part 3 (Day 1) |
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| Part 4, Period 1 (Days 1 to 5) |
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| Part 4, Washout Period (3 Days) |
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| Part 4, Period 2 (Days 1 to 5) |
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The safety population included all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1, (1A-1): PvP001 Placebo | PvP001 (TAK-062 liquid formulation) placebo-matching liquid, orally, single dose on Cohort Treatment Day in healthy participants. |
| BG001 | Part 1, (1B-1): PvP001 100 mg | PvP001 (TAK-062 liquid formulation) 100 mg, orally, single dose on Cohort Treatment Day in healthy participants. |
| BG002 | Part 1, (1C-1): PvP001 300 mg | PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in healthy participants. |
| BG003 | Part 1, (1D-1): PvP001 900 mg | PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in healthy participants. |
| BG004 | Part 1, (1E-1): PvP002 600 mg | PvP002 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in healthy participants. |
| BG005 | Part 1, (1A-2): PvP001 Placebo | PvP001 (TAK-062 liquid formulation) placebo-matching liquid, orally, single dose on Cohort Treatment Day in CeD participants. |
| BG006 | Part 1, (1B-2): PvP001 100 mg | PvP001 (TAK-062 liquid formulation) 100 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| BG007 | Part 1, (1C-2): PvP001 300 mg | PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| BG008 | Part 1, (1D-2): PvP001 900 mg | PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| BG009 | Part 1, (1E-2): PvP002 600 mg | PvP002 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| BG010 | Part 2, Group 1: PvP001 Placebo (2A) + PvP001 900 mg (2B) + PvP001 900 mg With PPI (2C) | PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| BG011 | Part 2, Group 1: PvP001 Placebo (2A) + PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) | PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C further followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| BG012 | Part 2, Group 1: PvP001 900 mg (2B) + PvP001 Placebo (2A) + PvP001 900 mg With PPI (2C) | PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, further followed by PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| BG013 | Part 2, Group 1: PvP001 900 mg (2B) + PvP001 900 mg With PPI (2C) + PvP001 Placebo (2A) | PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, further followed by PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| BG014 | Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 Placebo (2A) + PvP001 900 mg (2B) | PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, further followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| BG015 | Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A) | PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| BG016 | Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E) | PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| BG017 | Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D) | PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| BG018 | Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G) | PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| BG019 | Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F) | PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| BG020 | Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H) | PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| BG021 | Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F) | PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| BG022 | Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J) | PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| BG023 | Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I) | PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| BG024 | Part 3, Group 1: PvP003 Placebo (3A) + PvP003 600 mg (3B) | PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3A) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3A, followed by PvP003 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| BG025 | Part 3, Group 1: PvP003 600 mg (3B) + PvP003 Placebo (3A) | PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B, followed by PvP003 placebo-matching tablet (3A) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3A in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| BG026 | Part 3, Group 2: PvP003 Placebo (3C) + PvP003 600 mg (3D) | PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3C) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3C, followed by PvP003 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| BG027 | Part 3, Group 2: PvP003 600 mg (3D) + PvP003 Placebo (3C) | PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D, followed by PvP003 placebo-matching tablet (3C) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3C in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| BG028 | Part 3, Group 3: PvP003 Placebo (3E) + PvP003 600 mg (3F) | PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3E) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003 orally, single dose on Cohort Treatment Day of Cohort 3E, followed by PvP003 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003 orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| BG029 | Part 3, Group 3: PvP003 600 mg (3F) + PvP003 Placebo (3E) | PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003 orally, single dose on Cohort Treatment Day of Cohort 3F, followed by PvP003 placebo-matching tablet (3E) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3E, in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| BG030 | Part 3, Group 4: PvP003 Placebo (3G) + PvP003 600 mg (3H) | PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3G) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3G, followed by PvP003 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| BG031 | Part 3, Group 4: PvP003 600 mg (3H) + PvP003 Placebo (3G) | PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H, followed by PvP003 placebo-matching tablet (3G) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3G, in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| BG032 | Part 3, Group 5: PvP003 Placebo (3I) + PvP003 150 mg (3J) | PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3I) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3I, followed by PvP003 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| BG033 | Part 3, Group 5: PvP003 150 mg (3J) + PvP003 Placebo (3I) | PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J, followed by PvP003 placebo-matching tablet (3I) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3I in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| BG034 | Part 4: PvP003 Placebo, TID (4A) + PvP003 600 mg, TID (4B) | PvP003 (TAK-062 tablet formulation) placebo-matching tablet, administered as two tablets of PvP003 placebo, orally, TID on Treatment Days 1 to 5 (4A) of Cohort Treatment Period 1, followed by PvP003 600 mg administered as two tablets of PvP003 300 mg, orally, TID on Treatment Days 1 to 5 (4B) of Cohort Treatment Period 2 in healthy participants. There was a washout period of 3 days between the two Cohort Treatment Periods. |
| BG035 | Part 4: PvP003 600 mg, TID (4B) + PvP003 Placebo, TID (4A) | PvP003 (TAK-062 tablet formulation) 600 mg, administered as two tablets of PvP003 300 mg, orally, TID on Treatment Days 1 to 5 (4B) of Cohort Treatment Period 1, followed by PvP003 placebo-matching tablet, administered as two tablets of PvP003 placebo, orally, TID on Treatment Days 1 to 5 (4A) of Cohort Treatment Period 2 in healthy participants. There was a washout period of 3 days between the two Cohort Treatment Periods. |
| BG036 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002 | 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. | Posted | Count of Participants | Participants | Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) |
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| Primary | Part 4: Number of Participants Reporting One or More TEAEs for PvP003 After Multiple Doses | 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. | Posted | Count of Participants | Participants | Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up to Day 28) |
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| Primary | Part 1: Number of Participants Reporting One or More Treatment Emergent Serious Adverse Events (TESAEs) for PvP001 and PvP002 | 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. | Posted | Count of Participants | Participants | Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) |
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| Primary | Part 4: Number of Participants Reporting One or More TESAEs for PvP003 600 mg After Multiple Doses | 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. | Posted | Count of Participants | Participants | Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up to Day 28) |
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| Primary | 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. | Intent-to-Treat (ITT) population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 1, Cohort 2B (PvP001 900 mg) of Part 2 only. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure. | Posted | Median | Full Range | percentage of gluten degradation | Cohort Treatment Day |
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| Primary | 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. | ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 2, Cohort 2E (PvP002 600 mg) of Part 2 only. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure. | Posted | Median | Full Range | percentage of gluten degradation | Cohort Treatment Day |
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| Primary | 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. | ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 1, Cohort 2C (PvP001 900 mg) of Part 2 only. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure. | Posted | Median | Full Range | percentage of gluten degradation | Cohort Treatment Day |
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| Primary | 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. | ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 3, Cohort 2G (PvP001 300 mg) and Cohort 2H (PvP001 600 mg) of Part 2 only. | Posted | Median | Full Range | percentage of gluten degradation | Cohort Treatment Day: at 20 minutes post-dose |
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| Primary | 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. | ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 3, Cohort 2G (PvP001 300 mg) and Cohort 2H (PvP001 600 mg) of Part 2 only. | Posted | Median | Full Range | percentage of gluten degradation | Cohort Treatment Day: at 35 minutes post-dose |
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| Primary | 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. | ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 3, Cohort 2G (PvP001 300 mg) and Cohort 2H (PvP001 600 mg) of Part 2 only. | Posted | Median | Full Range | percentage of gluten degradation | Cohort Treatment Day: at 65 minutes post-dose |
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| Primary | 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. | ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 3, Cohort 2J (PvP001 900 mg) of Part 2 only. | Posted | Median | Full Range | percentage of gluten degradation | Cohort Treatment Day: at 20 minutes post-dose |
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| Primary | 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. | ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 3, Cohort 2J (PvP001 900 mg) of Part 2 only. | Posted | Median | Full Range | percentage of gluten degradation | Cohort Treatment Day: at 35 minutes post-dose |
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| Primary | 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. | ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 3, Cohort 2J (PvP001 900 mg) of Part 2 only. | Posted | Median | Full Range | percentage of gluten degradation | Cohort Treatment Day: at 65 minutes post-dose |
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| Primary | 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. | ITT population in Part 3 of study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed for Group 1, Cohort 3B (PvP003 600 mg), Group 2, Cohort 3D (PvP003 600 mg), Group 3, Cohort 3F (PvP003 600 mg), Group 4, Cohort 3H (PvP003 600 mg) and Group 5, Cohort 3J (PvP003 150 mg) of Part 3. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure. | Posted | Median | Full Range | percentage of gluten degradation | Cohort Treatment Day: at 35 minutes |
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| Primary | 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. | ITT population in Part 3 of study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed for Group 1, Cohort 3B (PvP003 600 mg), Group 2, Cohort 3D (PvP003 600 mg), Group 3, Cohort 3F (PvP003 600 mg), Group 4,Cohort 3H (PvP003 600 mg), Group 5, Cohort 3J (PvP003 150 mg) of Part 3. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure. | Posted | Median | Full Range | percentage of gluten degradation | Cohort Treatment Day: at 65 minutes |
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| Secondary | Part 1 and Part 2, Cmax: Maximum Observed Plasma Concentration for PvP001 and PvP002 | Pharmacokinetic (PK) population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Parts 1 and 2 PvP001 and PvP002; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms. | Posted | Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose |
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| Secondary | Part 1 and Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for PvP001 and PvP002 | PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Parts 1 and 2 PvP001 and PvP002; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms. | Posted | Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose |
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| Secondary | Part 1 and Part 2, T(1/2): Terminal Disposition Phase Half-life of PvP001 and PvP002 | PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Parts 1 and 2 PvP001 and PvP002; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms. | Posted | Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose |
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| Secondary | 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 | PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Parts 1 and 2 PvP001 and PvP002; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms. | Posted | Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose |
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| Secondary | Part 1 and Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for PvP001 and PvP002 | PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Parts 1 and 2 PvP001 and PvP002; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms. | Posted | Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose |
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| Secondary | Part 1 and Part 2: Number of Participants With Anti-drug Antibodies (ADA) for PvP001 and PvP002 | Safety population included all participants who received at least one dose of study drug. As planned, data was collected and analyzed at Day 14 and Day 28 after the final Cohort Treatment Day to test for ADA to PvP001 and PvP002; therefore, sequence-wise data is reported for Parts 1 and 2. | Posted | Count of Participants | Participants | At Day 14 and Day 28 |
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| Secondary | 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. | 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 (1B-1 and 1B-2, 1C-1 and 1C-2, 1D-1 and 1D-2) in healthy or CeD participants of the study. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure. | Posted | Number | mg | Cohort Treatment Day up to Day 7 |
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| Secondary | Part 2: Number of Participants Reporting One or More TEAEs and TESAEs for PvP001 and PvP002 | Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed only in the Part 2 of this study. | Posted | Count of Participants | Participants | Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22) |
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| Secondary | Part 3: Number of Participants Reporting One or More TEAEs and TESAEs With PvP003 After a Single Dose | Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed for Part 3 of this study. | Posted | Count of Participants | Participants | Cohort Treatment Day up to 5 days after final Cohort Treatment Day (up to Day 10) |
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| Secondary | Part 3, Cmax: Maximum Observed Plasma Concentration for PvP003 150 mg and 600 mg Single Dose | PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 3, PvP003 150 mg and 600 mg cohorts; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms. | Posted | Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose |
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| Secondary | Part 3, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for PvP003 150 mg and 600 mg Single Dose | PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 3, PvP003 150 mg and 600 mg cohorts; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms. | Posted | Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dose |
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| Secondary | Part 3, T(1/2): Terminal Disposition Phase Half-life of PvP003 150 mg and 600 mg Single Dose | PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 3, PvP003 150 mg and 600 mg cohorts; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms. | Posted | Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dose |
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| Secondary | 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 | PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 3, PvP003 150 mg and 600 mg cohorts; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms. | Posted | Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dose |
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| Secondary | Part 3, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for PvP003 150 mg and 600 mg Single Dose | PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 3, PvP003 150 mg and 600 mg cohorts; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms. | Posted | Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dose |
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| Secondary | Part 3: Number of Participants With ADA for PvP003 150 mg and 600 mg Single Dose | Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed only for Part 3 of this study. As planned, data was collected and analyzed at Day 14 and Day 28 after the final Cohort Treatment Day to test for ADA to PvP003; therefore, sequence-wise data is reported for Part 3. | Posted | Count of Participants | Participants | At Day 14 and Day 28 |
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| Secondary | Part 4, Cmax: Maximum Observed Plasma Concentration for PvP003 600 mg Multiple Dose | PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 4, PvP003 600 mg, TID (4B); however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms. | Posted | Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose |
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| Secondary | Part 4, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for PvP003 600 mg Multiple Dose | PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 4, PvP003 600 mg, TID (4B); however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time points for all arms. | Posted | Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose |
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| Secondary | Part 4, T(1/2): Terminal Disposition Phase Half-life of PvP003 600 mg Multiple Dose | PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 4, PvP003 600 mg, TID (4B); however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time points for all arms. | Posted | Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose |
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| Secondary | 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 | PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 4, PvP003 600 mg, TID (4B); however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time points for all arms. | Posted | Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose |
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| Secondary | Part 4, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for PvP003 600 mg Multiple Dose | PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 4, PvP003 600 mg, TID (4B); however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time points for all arms. | Posted | Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose |
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| Secondary | Part 4: Number of Participants With ADA for PvP003 600 mg Multiple Dose | 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 this study. As planned, data was collected and analyzed at Day 14 and Day 28 after Day 5 of the second Cohort Treatment Period to test for ADA to PvP003; therefore, sequence-wise data is reported for Part 4. | Posted | Count of Participants | Participants | At Day 14 and Day 28 |
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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
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Part 1, (1A-1): PvP001 Placebo | PvP001 (TAK-062 liquid formulation) placebo-matching liquid, orally, single dose on Cohort Treatment Day in healthy participants. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG001 | Part 1, (1B-1): PvP001 100 mg | PvP001 (TAK-062 liquid formulation) 100 milligram (mg), orally, single dose on Cohort Treatment Day in healthy participants. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | Part 1, (1C-1): PvP001 300 mg | PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in healthy participants. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG003 | Part 1, (1D-1): PvP001 900 mg | PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in healthy participants. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG004 | Part 1, (1E-1): PvP002 600 mg | PvP002 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in healthy participants. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG005 | Part 1, (1A-2): PvP001 Placebo | PvP001 (TAK-062 liquid formulation) placebo-matching liquid, orally, single dose on Cohort Treatment Day in CeD participants. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG006 | Part 1, (1B-2): PvP001 100 mg | PvP001 (TAK-062 liquid formulation) 100 mg, orally, single dose on Cohort Treatment Day in CeD participants. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG007 | Part 1, (1C-2): PvP001 300 mg | PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG008 | Part 1, (1D-2): PvP001 900 mg | PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG009 | Part 1, (1E-2): PvP002 600 mg | PvP002 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG010 | Part 2, Group 1: PvP001 Placebo (2A) | PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. | 0 | 13 | 0 | 13 | 1 | 13 |
| EG011 | Part 2, Group 1: PvP001 900 mg (2B) | PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG012 | Part 2, Group 1: PvP001 900 mg With PPI (2C) | PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. | 0 | 13 | 0 | 13 | 2 | 13 |
| EG013 | Part 2, Group 2: PvP002 Comparator (2D) | PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG014 | Part 2, Group 2: PvP002 600 mg (2E) | PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG015 | Part 2, Group 3: PvP001 Placebo (2F and 2I) | PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F and 2I in healthy participants. | 0 | 24 | 0 | 24 | 1 | 24 |
| EG016 | Part 2, Group 3: PvP001 300 mg (2G) | PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG017 | Part 2, Group 3: PvP001 600 mg (2H) | PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG018 | Part 2, Group 3: PvP001 900 mg (2J) | PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG019 | Part 3, Group 1: PvP003 Placebo (3A, 3C, 3E, 3G and 3I) | PvP003 (TAK-062 tablet formulation) placebo-matching tablet orally, single dose on Cohorts Treatment Day 1 of 3A, 3C, 3E, 3G or 3I in healthy participants. For Cohort 3A: with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal. For Cohorts 3C and 3I: without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal. For Cohort 3E: without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003; and for Cohort 3G: without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal. | 0 | 36 | 0 | 35 | 4 | 36 |
| EG020 | Part 3, Group 1: PvP003 600 mg (3B) | PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG021 | Part 3, Group 2: PvP003 600 mg (3D) | PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG022 | Part 3, Group 3: PvP003 600 mg (3F) | PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG023 | Part 3, Group 4: PvP003 600 mg (3H) | PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG024 | Part 3, Group 5: PvP003 150 mg (3J) | PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants. | 0 | 13 | 0 | 13 | 1 | 13 |
| EG025 | Part 4: PvP003 Placebo, TID (4A) | PvP003 (TAK-062 tablet formulation) placebo-matching tablet, administered as two tablets of PvP003 placebo, orally, TID on Treatment Days 1 to 5 (4A) of Cohort Treatment Period 1 or 2 in healthy participants. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG026 | Part 4: PvP003 600 mg, TID (4B) | PvP003 (TAK-062 tablet formulation) 600 mg, administered as two tablets of PvP003 300 mg, orally, TID on Treatment Days 1 to 5 (4B) of Cohort Treatment Period 1 or 2 in healthy participants. | 0 | 6 | 0 | 6 | 0 | 6 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2021 | Jun 21, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020714 | Maximum Tolerated Dose |
| ID | Term |
|---|---|
| D018675 | Toxicity Tests |
| D008919 | Investigative Techniques |
| D000069436 | Toxicological Phenomena |
| D002620 | Pharmacological and Toxicological Phenomena |
| D010829 | Physiological Phenomena |
Not provided
Not provided
| Subject Non-compliance |
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| Other |
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| Subject Decision |
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| Other |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG004 | Part 1, (1E-1): PvP002 600 mg | PvP002 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in healthy participants. |
| OG005 | Part 1, (1A-2): PvP001 Placebo | PvP001 (TAK-062 liquid formulation) placebo-matching liquid, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG006 | Part 1, (1B-2): PvP001 100 mg | PvP001 (TAK-062 liquid formulation) 100 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG007 | Part 1, (1C-2): PvP001 300 mg | PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG008 | Part 1, (1D-2): PvP001 900 mg | PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG009 | Part 1, (1E-2): PvP002 600 mg | PvP002 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
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| OG002 | Part 3, Group 3: PvP003 600 mg (3F) | PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants. |
| OG003 | Part 3, Group 4: PvP003 600 mg (3H) | PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants. |
| OG004 | Part 3, Group 5: PvP003 150 mg (3J) | PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants. |
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|
| OG002 | Part 3, Group 3: PvP003 600 mg (3F) | PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants. |
| OG003 | Part 3, Group 4: PvP003 600 mg (3H) | PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants. |
| OG004 | Part 3, Group 5: PvP003 150 mg (3J) | PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants. |
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PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in healthy participants.
| OG004 | Part 1, (1B-2): PvP001 100 mg | PvP001 (TAK-062 liquid formulation) 100 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG005 | Part 1, (1C-2): PvP001 300 mg | PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG006 | Part 1, (1D-2): PvP001 900 mg | PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG007 | Part 1, (1E-2): PvP002 600 mg | PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG008 | Part 2, Group 1: PvP001 900 mg (2B) | PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants. |
| OG009 | Part 2, Group 1: PvP001 900 mg With PPI (2C) | PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. |
| OG010 | Part 2, Group 2: PvP002 Placebo (2D) | PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. |
| OG011 | Part 2, Group 2: PvP002 600 mg (2E) | PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. |
| OG012 | Part 2, Group 3: PvP001 300 mg (2G) | PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. |
| OG013 | Part 2, Group 3: PvP001 600 mg (2H) | PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. |
| OG014 | Part 2, Group 3: PvP001 900 mg (2J) | PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. |
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PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in healthy participants.
| OG004 | Part 1, (1B-2): PvP001 100 mg | PvP001 (TAK-062 liquid formulation) 100 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG005 | Part 1, (1C-2): PvP001 300 mg | PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG006 | Part 1, (1D-2): PvP001 900 mg | PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG007 | Part 1, (1E-2): PvP002 600 mg | PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG008 | Part 2, Group 1: PvP001 900 mg (2B) | PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants. |
| OG009 | Part 2, Group 1: PvP001 900 mg With PPI (2C) | PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. |
| OG010 | Part 2, Group 2: PvP002 Placebo (2D) | PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. |
| OG011 | Part 2, Group 2: PvP002 600 mg (2E) | PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. |
| OG012 | Part 2, Group 3: PvP001 300 mg (2G) | PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. |
| OG013 | Part 2, Group 3: PvP001 600 mg (2H) | PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. |
| OG014 | Part 2, Group 3: PvP001 900 mg (2J) | PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. |
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PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in healthy participants.
| OG004 | Part 1, (1B-2): PvP001 100 mg | PvP001 (TAK-062 liquid formulation) 100 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG005 | Part 1, (1C-2): PvP001 300 mg | PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG006 | Part 1, (1D-2): PvP001 900 mg | PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG007 | Part 1, (1E-2): PvP002 600 mg | PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG008 | Part 2, Group 1: PvP001 900 mg (2B) | PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants. |
| OG009 | Part 2, Group 1: PvP001 900 mg With PPI (2C) | PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. |
| OG010 | Part 2, Group 2: PvP002 Placebo (2D) | PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. |
| OG011 | Part 2, Group 2: PvP002 600 mg (2E) | PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. |
| OG012 | Part 2, Group 3: PvP001 300 mg (2G) | PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. |
| OG013 | Part 2, Group 3: PvP001 600 mg (2H) | PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. |
| OG014 | Part 2, Group 3: PvP001 900 mg (2J) | PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. |
|
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in healthy participants. |
| OG004 | Part 1, (1B-2): PvP001 100 mg | PvP001 (TAK-062 liquid formulation) 100 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG005 | Part 1, (1C-2): PvP001 300 mg | PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG006 | Part 1, (1D-2): PvP001 900 mg | PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG007 | Part 1, (1E-2): PvP002 600 mg | PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG008 | Part 2, Group 1: PvP001 900 mg (2B) | PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants. |
| OG009 | Part 2, Group 1: PvP001 900 mg With PPI (2C) | PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. |
| OG010 | Part 2, Group 2: PvP002 Placebo (2D) | PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. |
| OG011 | Part 2, Group 2: PvP002 600 mg (2E) | PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. |
| OG012 | Part 2, Group 3: PvP001 300 mg (2G) | PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. |
| OG013 | Part 2, Group 3: PvP001 600 mg (2H) | PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. |
| OG014 | Part 2, Group 3: PvP001 900 mg (2J) | PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. |
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PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in healthy participants.
| OG004 | Part 1, (1B-2): PvP001 100 mg | PvP001 (TAK-062 liquid formulation) 100 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG005 | Part 1, (1C-2): PvP001 300 mg | PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG006 | Part 1, (1D-2): PvP001 900 mg | PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG007 | Part 1, (1E-2): PvP002 600 mg | PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG008 | Part 2, Group 1: PvP001 900 mg (2B) | PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants. |
| OG009 | Part 2, Group 1: PvP001 900 mg With PPI (2C) | PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. |
| OG010 | Part 2, Group 2: PvP002 Placebo (2D) | PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. |
| OG011 | Part 2, Group 2: PvP002 600 mg (2E) | PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. |
| OG012 | Part 2, Group 3: PvP001 300 mg (2G) | PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. |
| OG013 | Part 2, Group 3: PvP001 600 mg (2H) | PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. |
| OG014 | Part 2, Group 3: PvP001 900 mg (2J) | PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. |
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| OG004 | Part 1, (1E-1): PvP002 600 mg | PvP002 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in healthy participants. |
| OG005 | Part 1, (1A-2): PvP001 Placebo | PvP001 (TAK-062 liquid formulation) placebo-matching liquid, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG006 | Part 1, (1B-2): PvP001 100 mg | PvP001 (TAK-062 liquid formulation) 100 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG007 | Part 1, (1C-2): PvP001 300 mg | PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG008 | Part 1, (1D-2): PvP001 900 mg | PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG009 | Part 1, (1E-2): PvP002 600 mg | PvP002 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants. |
| OG010 | Part 2, Group 1: PvP001 Placebo (2A) + PvP001 900 mg (2B) + PvP001 900 mg With PPI (2C) | PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| OG011 | Part 2, Group 1: PvP001 Placebo (2A) + PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) | PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C further followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| OG012 | Part 2, Group 1: PvP001 900 mg (2B) + PvP001 Placebo (2A) + PvP001 900 mg With PPI (2C) | PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, further followed by PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| OG013 | Part 2, Group 1: PvP001 900 mg (2B) + PvP001 900 mg With PPI (2C) + PvP001 Placebo (2A) | PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, further followed by PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| OG014 | Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 Placebo (2A) + PvP001 900 mg (2B) | PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, further followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| OG015 | Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A) | PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| OG016 | Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E) | PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| OG017 | Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D) | PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| OG018 | Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G) | PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| OG019 | Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F) | PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| OG020 | Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H) | PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| OG021 | Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F) | PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| OG022 | Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J) | PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
| OG023 | Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I) | PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day. |
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PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
| OG004 | Part 2, Group 2: PvP002 600 mg (2E) | PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. |
| OG005 | Part 2, Group 3: PvP001 Placebo (2F and 2I) | PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F and 2I in healthy participants. |
| OG006 | Part 2, Group 3: PvP001 300 mg (2G) | PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. |
| OG007 | Part 2, Group 3: PvP001 600 mg (2H) | PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. |
| OG008 | Part 2, Group 3: PvP001 900 mg (2J) | PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. |
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| OG002 | Part 3, Group 2: PvP003 600 mg (3D) | PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants. |
| OG003 | Part 3, Group 3: PvP003 600 mg (3F) | PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants. |
| OG004 | Part 3, Group 4: PvP003 600 mg (3H) | PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants. |
| OG005 | Part 3, Group 5: PvP003 150 mg (3J) | PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants. |
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| OG003 | Part 3, Group 4: PvP003 600 mg (3H) | PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants. |
| OG004 | Part 3, Group 5: PvP003 150 mg (3J) | PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants. |
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| OG003 | Part 3, Group 4: PvP003 600 mg (3H) | PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants. |
| OG004 | Part 3, Group 5: PvP003 150 mg (3J) | PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants. |
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| OG003 | Part 3, Group 4: PvP003 600 mg (3H) | PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants. |
| OG004 | Part 3, Group 5: PvP003 150 mg (3J) | PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants. |
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| OG003 | Part 3, Group 4: PvP003 600 mg (3H) | PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants. |
| OG004 | Part 3, Group 5: PvP003 150 mg (3J) | PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants. |
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| OG003 | Part 3, Group 4: PvP003 600 mg (3H) | PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants. |
| OG004 | Part 3, Group 5: PvP003 150 mg (3J) | PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants. |
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| OG002 | Part 3, Group 2: PvP003 Placebo (3C) + PvP003 600 mg (3D) | PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3C) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3C, followed by PvP003 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| OG003 | Part 3, Group 2: PvP003 600 mg (3D) + PvP003 Placebo (3C) | PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D, followed by PvP003 placebo-matching tablet (3C) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3C in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| OG004 | Part 3, Group 3: PvP003 Placebo (3E) + PvP003 600 mg (3F) | PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3E) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3E, followed by PvP003 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| OG005 | Part 3, Group 3: PvP003 600 mg (3F) + PvP003 Placebo (3E) | PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3F, followed by PvP003 placebo-matching tablet (3E) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3E, in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| OG006 | Part 3, Group 4: PvP003 Placebo (3G) + PvP003 600 mg (3H) | PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3G) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3G, followed by PvP003 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| OG007 | Part 3, Group 4: PvP003 600 mg (3H) + PvP003 Placebo (3G) | PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H, followed by PvP003 placebo-matching tablet (3G) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3G, in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| OG008 | Part 3, Group 5: PvP003 Placebo (3I) + PvP003 150 mg (3J) | PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3I) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3I, followed by PvP003 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
| OG009 | Part 3, Group 5: PvP003 150 mg (3J) + PvP003 Placebo (3I) | PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J, followed by PvP003 placebo-matching tablet (3I) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3I in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day. |
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