CYP2C19 PoorPhase 1NCT00766025
Study in Taiwanese Subjects Identified as CYP2C19 Poor and Extensive Metabolizers Receiving Rosuvastatin
A Phase 1 study testing Rosuvastatin Calcium in people with CYP2C19 Poor and Extensive Metabolizers, run by AstraZeneca at 1 site in Taiwan.
Trial summary
The main purpose of this study is to examine Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers while taking single and multiple dosing a rosuvastatin calcium. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- CYP2C19 Poor, Extensive Metabolizers
- What is being tested?
- Rosuvastatin Calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2008to Feb 2009
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must have blood drawn for genotyping (determination of EM or PM of CYP2C19, determination of OATP-C1B1, BCRP 421C>A, and CYP2C9.
- Males and females aged 20-65, inclusive
- Women who are surgically sterilized, post-menopausal for at least one year, or not pregnant and/or lactating. Women of childbearing potential must be willing to abstain from sexual activity or use an effective contraception as outlined in protocol.
Who cannot join
- Subjects with deoxyribonucleic acid (DNA) that codes for OATP-C 1B1 *5 and *15, BCRP 421C>A and/or non wild-type CYP2C9
- History of adverse drug reaction or hypersensitivity to statins or drugs with a similar chemical structure to rosuvastatin
- History or presence of gastrointestinal, hepatic, or renal disease or other conditions known to interfere with absorption, distribution, metabolism and excretion (ADME) of drugs
- Any contraindication determined by review of a detailed medical and drug history, complete physical examination, vital signs, blood chemistry, hematology, and electrocardiogram (ECG)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open Label, Parallel Group, Single and Multiple Dose Study in Taiwanese Subjects Identified as CYP2C19 Poor Metabolizers or Extensive Metabolizers Receiving 20 Milligrams of Rosuvastatin Calcium
The main purpose of this study is to examine Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers while taking single and multiple dosing a rosuvastatin calcium.
- Conditions
- CYP2C19 Poor, Extensive Metabolizers
- Being tested
- Rosuvastatin Calcium
- Keywords
- Taiwanese Subjects, CYP2C19, Poor Metabolizers, Extensive Metabolizers, Taiwanese Subjects identified as CYP2C19 Poor or Extensive Metabolizers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin CalciumDrug
single oral dose on days 1, 4, 5, 6, 10-16, 17
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin Calcium | Experimental | Not described Receives: Drug: Rosuvastatin Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of rosuvastatin in Taiwanese subjects identified as CYP2CIP poor and extensive metabolizers
Measured: Scheduled times during the 18 days that the study drug is taken
Blood levels for assessment of pharmacodynamic (lipid) parameters
Measured: Days -1 and 18
Secondary outcomes (1)
Safety and tolerability of rosuvastatin in Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers
Measured: Screening through completion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startSep 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CYP2C19 PoorStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Regeio Mosquea-Garcia, MD, Study director, AstraZenecaRobin Meng, MD, PhD, Study director, AstraZenecaTzung-Dau Wang, MD, Principal investigator, Northern Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766025
- Sponsor's protocol ID
- D3560C00059
- Other IDs
- Rosuvastatin Calcium
- Status last verified
- Feb 2009
- First submitted
- 2 Oct 2008
- Last updated
- 2 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Parallel Group, Single and Multiple Dose Study in Taiwanese Subjects Identified as CYP2C19 Poor Metabolizers or Extensive Metabolizers Receiving 20 Milligrams of Rosuvastatin Calcium
- ClinicalTrials.gov ID
- NCT00766025
- Acronym / sponsor ID
- D3560C00059
- Conditions
- CYP2C19 Poor, Extensive Metabolizers
- Keywords
- Taiwanese Subjects, CYP2C19, Poor Metabolizers, Extensive Metabolizers, Taiwanese Subjects identified as CYP2C19 Poor or Extensive Metabolizers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Study completion
- Feb 2009 (actual)
- First posted
- 3 Oct 2008 (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.
The main purpose of this study is to examine Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers while taking single and multiple dosing a rosuvastatin calcium.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin Calcium | Experimental | Drug: Rosuvastatin Calcium |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must have blood drawn for genotyping (determination of EM or PM of CYP2C19, determination of OATP-C1B1, BCRP 421C>A, and CYP2C9.
- Males and females aged 20-65, inclusive
- Women who are surgically sterilized, post-menopausal for at least one year, or not pregnant and/or lactating. Women of childbearing potential must be willing to abstain from sexual activity or use an effective contraception as outlined in protocol.
Key exclusion criteria (4 listed)
- Subjects with deoxyribonucleic acid (DNA) that codes for OATP-C 1B1 *5 and *15, BCRP 421C>A and/or non wild-type CYP2C9
- History of adverse drug reaction or hypersensitivity to statins or drugs with a similar chemical structure to rosuvastatin
- History or presence of gastrointestinal, hepatic, or renal disease or other conditions known to interfere with absorption, distribution, metabolism and excretion (ADME) of drugs
- Any contraindication determined by review of a detailed medical and drug history, complete physical examination, vital signs, blood chemistry, hematology, and electrocardiogram (ECG)
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 |
|---|---|---|
| Rosuvastatin Calciumsingle oral dose on days 1, 4, 5, 6, 10-16, 17 | Drug | Rosuvastatin Calcium |
Primary outcome
Blood levels of rosuvastatin in Taiwanese subjects identified as CYP2CIP poor and extensive metabolizers
Time frame: Scheduled times during the 18 days that the study drug is taken
Blood levels for assessment of pharmacodynamic (lipid) parameters
Time frame: Days -1 and 18
1 secondary outcome
Safety and tolerability of rosuvastatin in Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers
Time frame: Screening through completion of the study
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 2 Mar 2009.
Related trials for CYP2C19 Poor
RecruitingPhase 2
Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice:
Pharmacogenomic Drug Interaction, Side Effect of Drug
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.
Regeio Mosquea-Garcia, MD study director
AstraZeneca
Robin Meng, MD, PhD study director
AstraZeneca
Tzung-Dau Wang, MD principal investigator
Northern Taiwan University Hospital
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 Rosuvastatin Calcium in people with CYP2C19 Poor and Extensive Metabolizers, run by AstraZeneca at 1 site in Taiwan.
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 3 inclusion and 4 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 2 Mar 2009. 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 Taiwan. 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?
Blood levels of rosuvastatin in Taiwanese subjects identified as CYP2CIP poor and extensive metabolizers (time frame: Scheduled times during the 18 days that the study drug is taken). The study lists 2 primary outcomes in all. 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 2 Mar 2009.