Healthy
Conditions
Keywords
T89 Safety in Healthy Japanese population
Brief summary
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.
Detailed description
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.
Interventions
DRUGT89 Group A
150mg single dose on day 1
DRUGPlacebo Group A
150mg single dose
DRUGPlacebo Group B
300mg single dose
DRUGT89 Group B
300mg single dose
DRUGPlacebo Group C
225mg bid
DRUGT89 Group C
225mg bid
Sponsors
Parexel
Tasly Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male and female volunteers aged between 20-55 years. 2. First generation of Japanese, and live in the U.S.A. less than 5 years and maintained Japanese lifestyle. 3. The body mass index between 18 and 30 kg/m2. 4. Willing to not take alcoholic beverages, and caffeine- and the bromine-containing beverages and foods (e.g., tea, coffee, chocolate, cola, etc.) for the duration of the study beginning at the screening visit. 5. ECG with no clinically significant abnormalities. 6. No clinically significant medical history. 7. Vital signs and laboratory tests with no clinically significant abnormalities. 8. Volunteers had not taken any medication that would interfere with the procedures or interpretation of study data or compromise subject safety within 4 weeks prior to the first dose, per principal investigator discretion. 9. Volunteers must understand and be willing, able and likely to comply with all study procedures and restrictions. 10. Volunteers must be able to give voluntary written informed consent.
Exclusion criteria
1. History of uncontrolled, clinically significant neurologic, cardiovascular, haematological, pulmonary, hepatic, renal, metabolic, GI, urologic, immunologic, endocrine or psychiatric disease. 2. Pregnant or nursing mother - Women of childbearing potential must have a negative pregnancy test, not be breast feeding and be established on a method of contraception that in the investigator's opinion is acceptable. 3. Have on-going other treatment or medicine that may interfere with T89 or administration of similar medication within 2 weeks of entering study, per principal investigator discretion. 4. Blood donor in recent 3 months. 5. Have taken part in other clinical trials involving administration of study medications in the previous 1 month before participation. 6. Excessive alcohol use (habitually consumed more than 21 units of alcohol per week or has a history of alcohol abuse as defined by DSM-IV-TR criteria (a unit of alcohol is equal to 1 ounce of hard liquor, 5 ounces of wine or 8 ounces of beer within past two years). 7. History or evidence of habitual use of tobacco or nicotine containing products within 3 months of Screening, with the exception of light smoking (up to 5 cigarettes per day or the equivalent) 8. Known hypersensitivity to any of the ingredients of T89 or other relevant drug allergy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Drug Events and Serious Adverse Events | 30 days (after first dosing) | the Incidence of Adverse Drug Events and serious adverse events |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Placebo Group A Placebo 150mg single dose | 2 |
| T89 Group A T89 150mg single dose | 4 |
| Placebo Group B Placebo 300mg single dose | 2 |
| T89 Group B T89 300mg single dose | 4 |
| Placebo Group C Placebo 225mg bid for 14 days | 2 |
| T89 Group C T89 225mg bid for 14 days | 6 |
| Total | 20 |
Baseline characteristics
| Characteristic | Placebo Group A | T89 Group A | Placebo Group B | T89 Group B | Placebo Group C | T89 Group C | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 27 years STANDARD_DEVIATION 3 | 24 years STANDARD_DEVIATION 2 | 24.5 years STANDARD_DEVIATION 4.9 | 24 years STANDARD_DEVIATION 2.2 | 47.5 years STANDARD_DEVIATION 6.4 | 40.6 years STANDARD_DEVIATION 9.9 | 32.5 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 2 participants | 4 participants | 2 participants | 4 participants | 2 participants | 6 participants | 20 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants | 4 Participants | 2 Participants | 5 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 4 | 0 / 2 | 0 / 4 | 0 / 2 | 1 / 6 |
| serious Total, serious adverse events | 0 / 2 | 0 / 4 | 0 / 2 | 0 / 4 | 0 / 2 | 0 / 6 |
Outcome results
Primary
Incidence of Adverse Drug Events and Serious Adverse Events
the Incidence of Adverse Drug Events and serious adverse events
Time frame: 30 days (after first dosing)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Group A | Incidence of Adverse Drug Events and Serious Adverse Events | 0 adverse event |
| T89 Group A | Incidence of Adverse Drug Events and Serious Adverse Events | 0 adverse event |
| Placebo Group B | Incidence of Adverse Drug Events and Serious Adverse Events | 0 adverse event |
| T89 Group B | Incidence of Adverse Drug Events and Serious Adverse Events | 0 adverse event |
| Placebo Group C | Incidence of Adverse Drug Events and Serious Adverse Events | 0 adverse event |
| T89 Group C | Incidence of Adverse Drug Events and Serious Adverse Events | 1 adverse event |