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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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The purpose of this study is to see how safe an investigational new drug (T89) is and how well healthy Japanese subjects tolerate it when given two single doses and a multiple dose.
This is a single centre, double-blind, randomized, placebo controlled, single- and multiple- dose-escalation study.
After informed consent is obtained, subjects were evaluated with a medical history questionnaire, physical examination, blood and urine collections for clinical laboratory safety tests, urine drug screen, serum pregnancy test for each women, vital signs and ECG. The subjects who fulfill the inclusion criteria but no exclusion criteria were provisionally enrolled. For participation in this trial, subjects were instructed to avoid any prescription, over-the-counter (OTC), and alternative / complementary medications or significant changes in diet without advance permission from principal investigator. The subjects were instructed to discontinue alcohol, caffeine and bromine containing beverage/food. 20 subjects were enrolled and divided into three Groups: Group A, Group B and Group C.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group A | Placebo Comparator | 150mg Placebo Single dose |
|
| T89 Group A | Experimental | 150mg T89 single dose |
|
| Placebo Group B | Placebo Comparator | 300mg placebo single dose |
|
| T89 Group B | Experimental | 300mg T89 single dose |
|
| Placebo Group C | Placebo Comparator | 225mg Placebo bid for 14 days |
|
| T89 Group C | Experimental | 225mg T89 bid for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T89 Group A | Drug | 150mg single dose on day 1 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Drug Events and Serious Adverse Events | the Incidence of Adverse Drug Events and serious adverse events | 30 days (after first dosing) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason GUO, M.D. | Tasly Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Clinical Trial Medical Group | Glendale | California | 91206 | United States |
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Study Initiation Date: Auguest 1st, 2012
Study Completion Date: October 20th, 2012
Location: Phase I clinical Study Center:
California Clinical Trials Medical Group 1509 Wilson Terrace Glendale, CA 91206
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Group A | Placebo 150mg single dose |
| FG001 | T89 Group A | T89 150mg single dose |
| FG002 | Placebo Group B | Placebo 300mg single dose |
| FG003 | T89 Group B | T89 300mg single dose |
| FG004 | Placebo Group C | Placebo 225mg bid for 14 days |
| FG005 | T89 Group C | T89 225mg bid for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Placebo Group A: 2 T89 Group A: 4 Placebo Group B: 2 T89 Group B: 4 Placebo Group C: 2 T89 Group C: 6
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Group A | Placebo 150mg single dose |
| BG001 | T89 Group A | T89 150mg single dose |
| 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 | Incidence of Adverse Drug Events and Serious Adverse Events | the Incidence of Adverse Drug Events and serious adverse events | Posted | Number | adverse event | 30 days (after first dosing) |
|
30 days after the last dose.
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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 | Placebo Group A | 150 mg Placebo Single dose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Henry SUN | Tasly Pharmaceuticals, Inc. | 240-744-6225 | henrysunusa@gmail.com |
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| ID | Term |
|---|---|
| C581239 | T89 herbal drug |
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| Placebo Group A | Drug | 150mg single dose |
|
| Placebo Group B | Drug | 300mg single dose |
|
| T89 Group B | Drug | 300mg single dose |
|
|
| Placebo Group C | Drug | 225mg bid |
|
| T89 Group C | Drug | 225mg bid |
|
|
| BG002 |
| Placebo Group B |
Placebo 300mg single dose |
| BG003 | T89 Group B | T89 300mg single dose |
| BG004 | Placebo Group C | Placebo 225mg bid for 14 days |
| BG005 | T89 Group C | T89 225mg bid for 14 days |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 |
| T89 Group B |
300mg T89; single dose |
| OG004 | Placebo Group C | 225mg bid for 10 days |
| OG005 | T89 Group C | T89 225mg bid for 10 days |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | T89 Group A | 150mg T89 single dose | 0 | 4 | 0 | 4 |
| EG002 | Placebo Group B | 300mg Placebo single dose | 0 | 2 | 0 | 2 |
| EG003 | T89 Group B | 300mg T89 single dose | 0 | 4 | 0 | 4 |
| EG004 | Placebo Group C | Placebo 225mg bid for 14 days | 0 | 2 | 0 | 2 |
| EG005 | T89 Group C | T89 225mf bid for 14 days | 0 | 6 | 1 | 6 |
PI can be co-authored with sponsor for the publication but cannot publish the result solely.