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Dose-Escalate Study to Investigate the Safety and Tolerability of T89 in Japanese

This study has been completed.
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Tasly Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01679028
First received: August 24, 2012
Last updated: November 16, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: T89 Group A
Drug: Placebo Group A
Drug: Placebo Group B
Drug: T89 Group B
Drug: Placebo Group C
Drug: T89 Group C
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Single- and Multiple- Dose-Escalation Study to Investigate the Safety and Tolerability of T89 in Japanese Healthy Volunteers

Further study details as provided by Tasly Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Incidence of Adverse Drug Events and Serious Adverse Events [ Time Frame: 30 days (after first dosing) ] [ Designated as safety issue: Yes ]
    the Incidence of Adverse Drug Events and serious adverse events


Enrollment: 20
Study Start Date: August 2012
Study Completion Date: February 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Group A
150mg Placebo Single dose
Drug: Placebo Group A
150mg single dose
Experimental: T89 Group A
150mg T89 single dose
Drug: T89 Group A
150mg single dose on day 1
Other Names:
  • Dantonic®
  • Salvtonic®
  • Compound Danshen Dripping Pills
Placebo Comparator: Placebo Group B
300mg placebo single dose
Drug: Placebo Group B
300mg single dose
Experimental: T89 Group B
300mg T89 single dose
Drug: T89 Group B
300mg single dose
Other Names:
  • Dantonic®
  • Salvtonic®
  • Compound Danshen Dripping Pills
Placebo Comparator: Placebo Group C
225mg Placebo bid for 14 days
Drug: Placebo Group C
225mg bid
Experimental: T89 Group C
225mg T89 bid for 14 days
Drug: T89 Group C
225mg bid
Other Names:
  • Dantonic®
  • Salvtonic®
  • Compound Danshen Dripping Pills

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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679028

Locations
United States, California
California Clinical Trial Medical Group
Glendale, California, United States, 91206
Sponsors and Collaborators
Tasly Pharmaceuticals, Inc.
Parexel
Investigators
Study Director: Jason GUO, M.D. Tasly Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Tasly Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01679028     History of Changes
Other Study ID Numbers: T89-10-JP
Study First Received: August 24, 2012
Results First Received: May 6, 2014
Last Updated: November 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Tasly Pharmaceuticals, Inc.:
T89 Safety in Healthy Japanese population

ClinicalTrials.gov processed this record on November 24, 2014