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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

August 24, 2012
November 16, 2014
August 2012
October 2012   (final data collection date for primary outcome measure)
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
Assessment of Safety including the incidence of adverse drug events, serious adverse events and lab abnormalities. [ Time Frame: 30 days (after first dosing) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01679028 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dose-Escalate Study to Investigate the Safety and Tolerability of T89 in Japanese
Single- and Multiple- Dose-Escalation Study to Investigate the Safety and Tolerability of T89 in Japanese Healthy Volunteers

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Healthy
  • Drug: T89 Group A
    150mg single dose on day 1
    Other Names:
    • Dantonic®
    • Salvtonic®
    • Compound Danshen Dripping Pills
  • Drug: Placebo Group A
    150mg single dose
  • Drug: Placebo Group B
    300mg single dose
  • Drug: T89 Group B
    300mg single dose
    Other Names:
    • Dantonic®
    • Salvtonic®
    • Compound Danshen Dripping Pills
  • Drug: Placebo Group C
    225mg bid
  • Drug: T89 Group C
    225mg bid
    Other Names:
    • Dantonic®
    • Salvtonic®
    • Compound Danshen Dripping Pills
  • Placebo Comparator: Placebo Group A
    150mg Placebo Single dose
    Intervention: Drug: Placebo Group A
  • Experimental: T89 Group A
    150mg T89 single dose
    Intervention: Drug: T89 Group A
  • Placebo Comparator: Placebo Group B
    300mg placebo single dose
    Intervention: Drug: Placebo Group B
  • Experimental: T89 Group B
    300mg T89 single dose
    Intervention: Drug: T89 Group B
  • Placebo Comparator: Placebo Group C
    225mg Placebo bid for 14 days
    Intervention: Drug: Placebo Group C
  • Experimental: T89 Group C
    225mg T89 bid for 14 days
    Intervention: Drug: T89 Group C
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2013
October 2012   (final data collection date for primary outcome measure)

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.
Both
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01679028
T89-10-JP
No
Tasly Pharmaceuticals, Inc.
Tasly Pharmaceuticals, Inc.
Parexel
Study Director: Jason GUO, M.D. Tasly Pharmaceuticals, Inc.
Tasly Pharmaceuticals, Inc.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP