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

• Sponsor: Tasly Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01679028
• Collaborator: Parexel (Industry)
• Enrollment: 20
• Location: 1
• Arms: 6
• Duration (Months): 6
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Official Title: Single- and Multiple- Dose-Escalation Study to Investigate the Safety and Tolerability of T89 in Japanese Healthy Volunteers
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

   the Incidence of Adverse Drug Events and serious adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tasly Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT01679028
• Other Study ID Numbers: T89-10-JP
• First Posted: Sep 5, 2012
• Last Update Posted: Nov 24, 2014
• Last Verified: Nov 1, 2014

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

Study Results

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

Arm/Group Title	Placebo Group A	T89 Group A	Placebo Group B	T89 Group B	Placebo Group C	T89 Group C
Arm/Group Description	Placebo 150mg single dose	T89 150mg single dose	Placebo 300mg single dose	T89 300mg single dose	Placebo 225mg bid for 14 days	T89 225mg bid for 14 days
Period Title: Overall Study
STARTED	2	4	2	4	2	6
COMPLETED	2	4	2	4	2	6
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Placebo Group A	T89 Group A	Placebo Group B	T89 Group B	Placebo Group C	T89 Group C	Total
Arm/Group Description	Placebo 150mg single dose	T89 150mg single dose	Placebo 300mg single dose	T89 300mg single dose	Placebo 225mg bid for 14 days	T89 225mg bid for 14 days	Total of all reporting groups
Overall Participants	2	4	2	4	2	6	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27 (3)	24 (2)	24.5 (4.9)	24 (2.2)	47.5 (6.4)	40.6 (9.9)	32.5 (11.0)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%	1 16.7%	1 5%
Male	2 100%	4 100%	2 100%	4 100%	2 100%	5 83.3%	19 95%
Region of Enrollment (participants) [Number]
United States	2 100%	4 100%	2 100%	4 100%	2 100%	6 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Incidence of Adverse Drug Events and Serious Adverse Events
Description	the Incidence of Adverse Drug Events and serious adverse events
Time Frame	30 days (after first dosing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Group A	T89 Group A	Placebo Group B	T89 Group B	Placebo Group C	T89 Group C
Arm/Group Description	150 mg placebo; single dose	150mg T89; Single dose	300mg Placebo; single dose	300mg T89; single dose	225mg bid for 10 days	T89 225mg bid for 10 days
Measure Participants	2	4	2	4	2	6
Number [adverse event]	0	0	0	0	0	1

Adverse Events

Time Frame	30 days after the last dose.
Arm/Group Title	Placebo Group A		T89 Group A		Placebo Group B		T89 Group B		Placebo Group C		T89 Group C
Arm/Group Description	150 mg Placebo Single dose		150mg T89 single dose		300mg Placebo single dose		300mg T89 single dose		Placebo 225mg bid for 14 days		T89 225mf bid for 14 days
All Cause Mortality
	Placebo Group A		T89 Group A		Placebo Group B		T89 Group B		Placebo Group C		T89 Group C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo Group A		T89 Group A		Placebo Group B		T89 Group B		Placebo Group C		T89 Group C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/4 (0%)		0/2 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Placebo Group A		T89 Group A		Placebo Group B		T89 Group B		Placebo Group C		T89 Group C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/4 (0%)		0/2 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)
General disorders
Somnolence	0/2 (0%)		0/4 (0%)		0/2 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

PI can be co-authored with sponsor for the publication but cannot publish the result solely.