Stable AnginaPhase 1NCT01473888
A Study To Evaluate The Effect of T89(Dantonic®)On P450 Enzymes
A Phase 1 study testing T89(Dantonic) in people with Stable Angina, run by Tasly Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stable Angina
- What is being tested?
- T89(Dantonic)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
- Presence of any condition that the investigator feels would interfere with successful completion of the study.
- Genotyping of poor metabolizers for CYP2D6, CYP2C9, and CYP2C19.
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Clinical Development NW Inc.
Tacoma, Washington, 98418
About this study
Official title: An Open-label, One-sequence, Two Periods, Crossover Trial Study to Evaluate the Effect of T89 on the Pharmacokinetics of Five CYP450 Substrates Cocktail in Healthy Subjects
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.
Read the detailed description
T89 is a modernized and industrialized version of a traditional Chinese herbal medicine. T89 was approved for marketing as a drug, for the treatment of chronic stable angina pectoris due to coronary heart disease, by the State Food and Drug Administration (SFDA) of China in 1993. There were more than 2 billion doses have been prescribed or used, in about 10,000,000 subjects, in short or long-term administration worldwide.
The product is also marketed, as a drug, in Russia, South Korea, Mongolia, Singapore, Vietnam, and South Africa. The current study is to determine the anti-angina effect and dose response of T89 in patients with chronic stable angina pectoris in the United States.
T89 consists of Danshen (Radix Salviae Miltiorrhizae, RSM) and Sanqi (Radix Notoginseng, RN) as active constitutes, and using Borneol as transporting enhancer.
- Conditions
- Stable Angina
- Being tested
- T89(Dantonic)
- Keywords
- T89(Dantonic®), Cooperstown 5+1 cocktail probes, CYP450
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T89(Dantonic)Drug
capsule, 225mg B.I.D.
| Study group | Role | What they receive |
|---|---|---|
| T89 | Other | Not described Receives: Drug: T89(Dantonic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 25 days (From Day 1 to Day 25)
Secondary outcomes (1)
Safety assessments (AEs, Vital signs, ECG, Safety labs, INRs)
Measured: subjects will be followed for the safety assessment from Day 0 to Day 35.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Zhixin GUO, M.D., Study director, Tasly Pharmaceuticals Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473888
- Sponsor's protocol ID
- T89-02-US
- Status last verified
- Nov 2011
- First submitted
- 31 Oct 2011
- Last updated
- 8 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, One-sequence, Two Periods, Crossover Trial Study to Evaluate the Effect of T89 on the Pharmacokinetics of Five CYP450 Substrates Cocktail in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01473888
- Acronym / sponsor ID
- T89-02-US
- Conditions
- Stable Angina
- Keywords
- T89(Dantonic®), Cooperstown 5+1 cocktail probes, CYP450
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tasly Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
T89 is a modernized and industrialized version of a traditional Chinese herbal medicine. T89 was approved for marketing as a drug, for the treatment of chronic stable angina pectoris due to coronary heart disease, by the State Food and Drug Administration (SFDA) of China in 1993. There were more than 2 billion doses have been prescribed or used, in about 10,000,000 subjects, in short or long-term administration worldwide.
The product is also marketed, as a drug, in Russia, South Korea, Mongolia, Singapore, Vietnam, and South Africa. The current study is to determine the anti-angina effect and dose response of T89 in patients with chronic stable angina pectoris in the United States.
T89 consists of Danshen (Radix Salviae Miltiorrhizae, RSM) and Sanqi (Radix Notoginseng, RN) as active constitutes, and using Borneol as transporting enhancer.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T89 | Other | Drug: T89(Dantonic) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T89(Dantonic)capsule, 225mg B.I.D. | Drug | T89 |
Primary outcome
The PK variables of the cocktail substrates with and without T89.
Time frame: 25 days (From Day 1 to Day 25)
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;
1 secondary outcome
Safety assessments (AEs, Vital signs, ECG, Safety labs, INRs)
Time frame: subjects will be followed for the safety assessment from Day 0 to Day 35.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2012.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Zhixin GUO, M.D. study director
Tasly Pharmaceuticals Co. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing T89(Dantonic) in people with Stable Angina, run by Tasly Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The PK variables of the cocktail substrates with and without T89. (time frame: 25 days (From Day 1 to Day 25)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2012.