NCT01473888

Brief Summary

Purpose: This study is to determine the effect of T89(Dantonic®)on P450 enzymes. This study will help determine which types of drugs may interact with T89.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

November 8, 2012

Status Verified

November 1, 2011

Enrollment Period

6 months

First QC Date

October 31, 2011

Last Update Submit

November 7, 2012

Conditions

Stable Angina

Keywords

T89(Dantonic®)Cooperstown 5+1 cocktail probesCYP450

Outcome Measures

Primary Outcomes (1)

  • The PK variables of the cocktail substrates with and without T89.

    caffine: AUC(0-12h)\&Cmax; Omeprazole:AUC(0-12h)\& Cmax; Midazolam:AUC(0-12h)\& Cmax; Dextromethorphan:Dextromethorphan/Dextrorphan(12h Urine) S-warfarin: AUC(0-96h)\& Cmax;

    25 days (From Day 1 to Day 25)

Secondary Outcomes (1)

  • Safety assessments (AEs, Vital signs, ECG, Safety labs, INRs)

    subjects will be followed for the safety assessment from Day 0 to Day 35.

Study Arms (1)

T89

OTHER
Drug: T89(Dantonic)

Interventions

T89(Dantonic)DRUG

capsule, 225mg B.I.D.

T89

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Nonsmoking Male or female 18-50 years of age, with a body mass index (BMI)18 to ≤ 30 kg/m2
  • Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam and laboratory evaluations;
  • Avoid eating Seville oranges, grapefruits (including grapefruit juice), broccoli, brussels sprouts, charcoal-grilled meats, alcoholic beverages, and caffeine- and theobromine-containing beverages and foods for the duration of the study beginning at the screening visit.
  • Females of child bearing potential must be able to maintain adequate birth control during the study; defined as double barrier method or complete abstinence. Females of non-child bearing potential must provide documentation of tubal ligation or hysterectomy.
  • Be able to provide written informed consent and comply with requirements of the study;
  • Be able to read, speak and understand English

You may not qualify if:

  • Clinically significant abnormal findings by history, physical exam, ECG, or laboratory testing as determined by the study doctor.
  • Know hypersensitivity or intolerance to any of the probe substrates or the active and/or inactive ingredients in the probe substrates, flumazenil, guaifenesin, or vitamin K;
  • A history of illicit drug use or a history of alcohol abuse within 1 year of screening.
  • Women who are pregnant, breastfeeding, and/or not using an acceptable form of non-hormonal contraception (double barrier method or abstinence) during the study.
  • History of gastrointestinal bleeding or peptic ulcer disease.
  • Any condition that may affect drug absorption (e.g., gastrectomy, malabsorption syndromes).
  • Had an elevated international normalized ratio (INR) time (INR\> 1.2) at screening or Day-1.
  • Had taken any nicotine-containing or nicotine replacement devices within 6 months before the screening visit
  • Had taken any prescription drugs during the 3 months before the screening visit
  • Had taken any nonprescription drugs (including natural health products, Vitamins, and herbals) during a period of 7 days prior to the screening visit
  • Had received an immunization during the 2 weeks prior to the screening visit
  • Had known immune deficiency disease or were positive for human immunodeficiency virus, Hepatitis B or Hepatitis C virus.
  • Use of any drug known to inhibit or induce hepatic enzymes within 30 days of the first study phase.
  • Regular alcohol intake exceeding 1 drink/day (1 drink = 5 ounces of wine or 12 ounces of beer or 1 ounce of hard liquor) within 7 days of screening.
  • Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study drug.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Clinical Development NW Inc.

Tacoma, Washington, 98418, United States

Location

Related Links

MeSH Terms

Conditions

Angina, Stable

Interventions

T89 herbal drug

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jason Zhixin GUO, M.D.

    Tasly Pharmaceuticals Co. Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2011

First Posted

November 17, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2011

Study Completion

January 1, 2012

Last Updated

November 8, 2012

Record last verified: 2011-11

Locations

US(1)