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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1197-3577 | Registry Identifier | WHO |
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The purpose of this study is to assess the PK of vedolizumab following a single intravenous infusion in healthy adult Chinese participants.
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis (UC) or Crohn's disease (CD). This study will look at the PK, safety, and tolerability of vedolizumab following a single intravenous infusion of vedolizumab IV in healthy adult Chinese participants.
The study will enroll approximately 16 participants. All participants will be assigned to receive a single dose of vedolizumab IV 300 mg on Day 1.
This single center trial will be conducted in China. The overall time to participate in this study is approximately 7 months. Participants will make multiple visits to the clinic, and will be contacted by telephone, 6 months after single dose of study drug for a follow-up safety survey assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vedolizumab 300 mg | Experimental | Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vedolizumab | Drug | Vedolizumab intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Serum Concentration for Vedolizumab | Day 1 pre-dose and at multiple time points (up to Day 127) post-dose | |
| AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab | Day 1 pre-dose and at multiple time points (up to Day 127) post-dose | |
| AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab | Day 1 pre-dose and at multiple time points (up to Day 127) post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Positive Anti-vedolizumab Antibody (AVA) | Day 1 pre-dose and at multiple time points (up to Day 127) post-dose | |
| Percentage of Participants With Positive Neutralizing AVA | Day 1 pre-dose and at multiple time points (up to Day 127) post-dose |
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Inclusion Criteria:
1. The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 19.0 to 26.0 kilogram per square meter (kg/m^2) inclusive at Screening.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Healthy Chinese participants were enrolled to receive a single dose of vedolizumab intravenous 300 milligram (mg).
Participants took part in the study at 1 investigative site in China from 05 March 2018 to 05 September 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vedolizumab 300 mg | Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The safety analysis set consisted of all participants who were enrolled and received 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vedolizumab 300 mg | Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax: Maximum Observed Serum Concentration for Vedolizumab | The pharmacokinetic (PK) analysis set consisted of all participants who received study drug and had at least 1 measurable serum concentration. | Posted | Geometric Mean | Standard Deviation | microgram per milliliter (mcg/mL) | Day 1 pre-dose and at multiple time points (up to Day 127) post-dose |
|
|
Treatment emergent adverse events (TEAE) are adverse events that started after the infusion of study drug and no more than Day 127
At each visit the investigator had to assess any occurrence of adverse events. Participants may report AES occurring at any other time during the study. 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 | Vedolizumab 300 mg | Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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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 | May 10, 2018 | Jul 23, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2018 | Jul 23, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C543529 | vedolizumab |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeter (cm) |
|
| Weight | Mean | Standard Deviation | kilogram (kg) |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
|
|
| Primary | AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab | The PK analysis set consisted of all participants who received study drug and had at least 1 measurable serum concentration. | Posted | Geometric Mean | Standard Deviation | day*microgram per milliliter(day*mcg/mL) | Day 1 pre-dose and at multiple time points (up to Day 127) post-dose |
|
|
|
| Primary | AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab | The PK analysis set consisted of all participants who received study drug and had at least 1 measurable serum concentration. | Posted | Geometric Mean | Standard Deviation | day*mcg/mL | Day 1 pre-dose and at multiple time points (up to Day 127) post-dose |
|
|
|
| Secondary | Percentage of Participants With Positive Anti-vedolizumab Antibody (AVA) | The safety analysis set consisted of all participants who were enrolled and received 1 dose of study drug. | Posted | Number | percentage of participants | Day 1 pre-dose and at multiple time points (up to Day 127) post-dose |
|
|
|
| Secondary | Percentage of Participants With Positive Neutralizing AVA | The safety analysis set consisted of all participants who were enrolled and received 1 dose of study drug. | Posted | Number | percentage of participants | Day 1 pre-dose and at multiple time points (up to Day 127) post-dose |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 6 |
| 16 |
| Blood creatine phosphokinase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Leukocyturia | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
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.
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |