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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1224-9867 | Registry Identifier | WHO |
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The purpose of this study is to evaluate the effect of the proton pump inhibitor (PPI) esomeprazole on the single-dose PK of orally administered TAK-906.
The drug being tested in this study is called TAK-906. TAK-906 is being tested in healthy participants to evaluate the effect of a PPI esomeprazole on the PK of TAK-906.
The study will enroll approximately 12 participants. Participants will be assigned to the following treatment sequence:
• TAK-906 25 mg; Esomeprazole 40 mg + TAK-906 25 mg
All participants will be given an oral dose of TAK-906 and Esomeprazole.
This single center trial will be conducted in the United States. The overall duration to participate in this study is 52 days. Participants will make visit to the clinic during Period 1 and Period 2 in addition to approximately 10 to 14 days after receiving their last dose of TAK-906 for a follow up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-906 25 mg; Esomeprazole 40 mg + TAK-906 25 mg | Experimental | TAK-906 25 milligram (mg), capsule, orally, once on Day 1 of Study Period 1, followed by a washout period of at least 4 days, further followed by esomeprazole 40 mg, capsule, orally, once daily on Days 1 to 5 along with TAK-906 25 mg, capsule, orally, once on Day 4 of Study Period 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-906 | Drug | TAK-906 capsules. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for TAK-906 | TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose | |
| AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 | TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 dose | |
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 | TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Grade 3 or Higher TEAEs | A severity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Grade 1 scales as Mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 scales as Moderate (minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL); Grade 3 scales as severe(severe or medically significant but not immediately life threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 scales as life-threatening consequences, urgent intervention indicated, and Grade 5 scales as death related to AE. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35218604 | Derived | Kaur Mukker J, Dukes G, Wang L, Huh S, Khudyakov P, Nishihara M, Chen C. Evaluation of the pharmacokinetics of trazpiroben (TAK-906) in the presence and absence of the proton pump inhibitor esomeprazole. Clin Transl Sci. 2022 May;15(5):1281-1290. doi: 10.1111/cts.13248. Epub 2022 Feb 26. |
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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 were enrolled in this single sequence, 2-period cross-over design study to receive TAK-906 25 milligram (mg) in Study Period 1 followed by esomeprazole 40 mg and TAK-906 25 mg in Study Period 2.
Participants took part in the study at 1 investigative site in the Unites states from 27 February 2019 to 15 April 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAK-906 25 mg + Esomeprazole 40 mg and TAK-906 25 mg | TAK-906 25 mg, capsule, orally, once on Day 1 of Study Period 1, followed by a washout period of at least 4 days, further followed by esomeprazole 40 mg, capsule, orally, once daily on Days 1 to 5 along with TAK-906 25 mg, capsule, orally, once on Day 4 of Study Period 2. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (3 Days) |
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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 | Feb 4, 2019 | Mar 17, 2020 |
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| Esomeprazole | Drug | Esomeprazole capsules. |
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| Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23) |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23) |
| Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) | Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23) |
| Number of Participants With Clinically Significant Change From Baseline Clinical Laboratory Values | Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23) |
| COMPLETED |
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| NOT COMPLETED |
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| Washout Period (at Least 4 Days) |
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| Period 2 (6 Days) |
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The safety set included all participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | TAK-906 25 mg + Esomeprazole 40 mg and TAK-906 25 mg | TAK-906 25 mg, capsule, orally, once on Day 1 of Study Period 1, followed by a washout period of at least 4 days, further followed by esomeprazole 40 mg, capsule, orally, once daily on Days 1 to 5 along with TAK-906 25 mg, capsule, orally, once on Day 4 of Study Period 2. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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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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| Weight | Mean | Standard Deviation | kilogram (kg) |
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| Height | Mean | Standard Deviation | centimeter (cm) |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
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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 | Cmax: Maximum Observed Plasma Concentration for TAK-906 | The pharmacokinetic (PK) set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations). | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose |
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| Primary | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations). | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 dose |
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| Primary | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 dose |
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| Secondary | Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Grade 3 or Higher TEAEs | A severity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Grade 1 scales as Mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 scales as Moderate (minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL); Grade 3 scales as severe(severe or medically significant but not immediately life threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 scales as life-threatening consequences, urgent intervention indicated, and Grade 5 scales as death related to AE. | The safety set included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23) |
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| Secondary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | The safety set included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23) |
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| Secondary | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) | The safety set included all participants who received at least one dose of study drug. The safety set where data at specified time points was available. | Posted | Count of Participants | Participants | Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23) |
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| Secondary | Number of Participants With Clinically Significant Change From Baseline Clinical Laboratory Values | The safety set included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23) |
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TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAK-906 25 mg | TAK-906 25 mg, capsule, orally, once on Day 1 of Study Period 1. | 0 | 12 | 0 | 12 | 2 | 12 |
| EG001 | Esomeprazole 40 mg | Esomeprazole 40 mg, capsule, orally, once daily on Days 1 to 5 of Study Period 2. | 0 | 12 | 0 | 12 | 1 | 12 |
| EG002 | Esomeprazole 40 mg and TAK-906 25 mg | Esomeprazole 40 mg, capsule, orally, once daily on Days 1 to 5 along with TAK-906 25 mg, capsule, orally, once on Day 4 of Study Period 2. | 0 | 12 | 0 | 12 | 3 | 12 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza like illness | General disorders | MedDRA (21.1) | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA (21.1) | Systematic Assessment |
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| Vessel puncture site reaction | General disorders | MedDRA (21.1) | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
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| Menstruation delayed | Reproductive system and breast disorders | MedDRA (21.1) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | 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 | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 22, 2019 | Mar 17, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000720755 | trazpiroben |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Unknown or Not Reported |
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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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Esomeprazole 40 mg, capsule, orally, once daily on Days 1 to 5 along with TAK-906 25 mg, capsule, orally, once on Day 4 of Study Period 2. |
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