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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
Results First Received: May 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator)
Condition: Healthy
Interventions: Drug: T89 Group A
Drug: Placebo Group A
Drug: Placebo Group B
Drug: T89 Group B
Drug: Placebo Group C
Drug: T89 Group C

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

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


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Group A Placebo 150mg single dose
T89 Group A T89 150mg single dose
Placebo Group B Placebo 300mg single dose
T89 Group B T89 300mg single dose
Placebo Group C Placebo 225mg bid for 14 days
T89 Group C T89 225mg bid for 14 days

Participant Flow:   Overall Study
    Placebo Group A     T89 Group A     Placebo Group B     T89 Group B     Placebo Group C     T89 Group C  
STARTED     2     4     2     4     2     6  
COMPLETED     2     4     2     4     2     6  
NOT COMPLETED     0     0     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Placebo Group A: 2 T89 Group A: 4 Placebo Group B: 2 T89 Group B: 4 Placebo Group C: 2 T89 Group C: 6

Reporting Groups
  Description
Placebo Group A Placebo 150mg single dose
T89 Group A T89 150mg single dose
Placebo Group B Placebo 300mg single dose
T89 Group B T89 300mg single dose
Placebo Group C Placebo 225mg bid for 14 days
T89 Group C T89 225mg bid for 14 days
Total Total of all reporting groups

Baseline Measures
    Placebo Group A     T89 Group A     Placebo Group B     T89 Group B     Placebo Group C     T89 Group C     Total  
Number of Participants  
[units: participants]
  2     4     2     4     2     6     20  
Age  
[units: years]
Mean ± Standard Deviation
  27  ± 3     24  ± 2     24.5  ± 4.9     24  ± 2.2     47.5  ± 6.4     40.6  ± 9.9     32.5  ± 11.0  
Gender  
[units: participants]
             
Female     0     0     0     0     0     1     1  
Male     2     4     2     4     2     5     19  
Region of Enrollment  
[units: participants]
             
United States     2     4     2     4     2     6     20  



  Outcome Measures

1.  Primary:   Incidence of Adverse Drug Events and Serious Adverse Events   [ Time Frame: 30 days (after first dosing) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Henry SUN
Organization: Tasly Pharmaceuticals, Inc.
phone: 240-744-6225
e-mail: henrysunusa@gmail.com


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