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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1240-6352 | Other Identifier | WHO |
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The purpose of this study is to evaluate the effect of single dose intravenous rifampin 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 to evaluate the effect of single dose intravenous rifampin on the single-dose PK of oral TAK-906 in healthy adult participants.
The study will enroll approximately 12 participants. Participants will be randomly assigned to one of the two treatment sequences AB or BA:
This single center trial will be conducted in the United States. The overall time to participate in this study is 49 Days. All participants will make final visit 14 days after receiving their last dose of study drug for follow up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence AB: TAK-906 25 mg + TAK-906 25 mg and Rifampin 600 mg | Experimental | TAK-906 25 milligram (mg) (Treatment A), capsule, orally, once on Day 1 of Study Period 1, followed by a washout period of at least 7 days, further followed by rifampin 600 mg, infusion, once, intravenously over 30 minutes along with TAK-906 25 mg (Treatment B), capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 2. |
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| Sequence BA: TAK-906 25 mg and Rifampin 600 mg + TAK-906 25 mg | Experimental | Rifampin 600 mg, infusion, once, intravenously over 30 minutes along with TAK-906 25 mg (Treatment B), capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 1 followed by a washout period of at least 7 days, further followed by TAK-906 25 mg (Treatment A), capsule, orally, once on Day 1 of Study Period 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-906 | Drug | TAK-906 capsule. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for TAK-906 | Day 1: time zero and at multiple time points (up to 48 hours) post dose | |
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 | Day 1: time zero and at multiple time points (up to 48 hours) post dose | |
| AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 | Day 1: time zero and at multiple time points (up to 48 hours) post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23) | |
| Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values |
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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 | Lincoln | Nebraska | 68502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35460165 | Derived | Mukker JK, Dukes G, Tolkoff M, Wang L, Almansa C, Huh SY, Nishihara M, Ramsden D, Chen C. The pharmacokinetics of oral trazpiroben (TAK-906) after organic anion transporting polypeptide 1B1/1B3 inhibition: A phase I, randomized study. Clin Transl Sci. 2022 Jun;15(6):1532-1543. doi: 10.1111/cts.13274. Epub 2022 May 5. |
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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 1 of the 2 treatment sequences of this 2-period crossover study to receive TAK-906 25 milligram (mg) alone (Treatment A) and TAK-906 25 mg along with rifampin 600 mg (Treatment B).
Participants took part in the study at 1 investigative site in the United States from 15 October 2019 to 16 November 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence AB: TAK-906 25 mg + TAK-906 25 mg and Rifampin 600 mg | TAK-906 25 mg (Treatment A), capsule, orally, once on Day 1 of Study Period 1, followed by a washout period of at least 7 days, further followed by rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg (Treatment B), capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 2. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Study Period 1 (1 Day) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 2, 2019 | Nov 13, 2020 |
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| Rifampin | Drug | Rifampin infusion. |
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| Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23) |
| Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings | Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23) |
| Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values | Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23) |
| FG001 | Sequence BA: TAK-906 25 mg and Rifampin 600 mg + TAK-906 25 mg | Rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg (Treatment B), capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 1, followed by a washout period of at least 7 days, further followed by TAK-906 25 mg (Treatment A), capsule, orally, once on Day 1 of Study Period 2. |
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| NOT COMPLETED |
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| Washout Period (at Least 7 Days) |
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| Study Period 2 (1 Day) |
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The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence AB: TAK-906 25 mg + TAK-906 25 mg and Rifampin 600 mg | TAK-906 25 mg (Treatment A), capsule, orally, once on Day 1 of Study Period 1, followed by a washout period of at least 7 days, further followed by rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg (Treatment B), capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 2. |
| BG001 | Sequence BA: TAK-906 25 mg and Rifampin 600 mg + TAK-906 25 mg | Rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg (Treatment B), capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 1, followed by a washout period of at least 7 days, further followed by TAK-906 25 mg (Treatment A), capsule, orally, once on Day 1 of Study Period 2. |
| BG002 | Total | Total of all reporting groups |
| 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/Ethnicity, Customized | 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 consisted of all participants who received study drug and had at least 1 measurable plasma concentration. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 1: time zero and at multiple time points (up to 48 hours) post 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 consisted of all participants who received study drug and had at least 1 measurable plasma concentration. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Day 1: time zero and at multiple time points (up to 48 hours) post 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 consisted of all participants who received study drug and had at least 1 measurable plasma concentration. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1: time zero and at multiple time points (up to 48 hours) post dose |
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| Secondary | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23) |
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| Secondary | Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values | The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23) |
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| Secondary | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings | The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23) |
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| Secondary | Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values | The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23) |
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TEAEs are adverse events (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 (up to Day 23)
At each visit the investigator had to document any occurrence of AEs 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 | Treatment A: TAK-906 25 mg | TAK-906 25 mg, capsule, orally, once on Day 1 of either Study Period 1 or 2. | 0 | 12 | 0 | 12 | 6 | 12 |
| EG001 | Treatment B: Rifampin 600 mg and TAK-906 25 mg | Rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg, capsule, orally, once immediately after the end of infusion on Day 1 of either Study Period 1 or 2. | 0 | 12 | 0 | 12 | 2 | 12 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
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| Sensory disturbance | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (22.1) | 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 |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 24, 2019 | Nov 13, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| C000720755 | trazpiroben |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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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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| Black or African American |
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| Black or African American, White |
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| White |
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