Organic Anion Transporting Polypeptide1B1 (OATP1B1)Phase 4OATPNCT01218347
Influence of Organic Anion Transporting Polypeptide1B1(OATP1B1) Genotype on Rosuvastatin PK, PD and Lipid Profiles
A Phase 4 study testing Rosuvastatin in people with Organic Anion Transporting Polypeptide1B1 (OATP1B1) and Rosuvastatin, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aimed to explore the influence of organic anion transporting polypeptide1B1 (OATP1B1) genotype on pharmacokinetics, lipid lowering effect and lipid profiles after rosuvastatin administration. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Organic Anion Transporting Polypeptide1B1 (OATP1B1), Rosuvastatin
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2010to Dec 2010
- Phase
- Phase 4
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: Between 20 to 50 years of age, inclusive (age based on the date to give the informed consent)
- Weight: Over 55 kg, within ±20% of ideal body weight
- Must be reliable and willing to make themselves available during the study period
- Must be willing to give blood sample for genotyping
Who cannot join
- History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease
- History of a significant surgical resection of gastrointestinal tract except appendectomy
- History or evidence of drug abuse
- Use any medication during the last 14 days period before first dosing
- Hypersensitivity to HMG-CoA reductase inhibitor
- Judged to be inappropriate for the study by the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trials Center, Seoul National University Hospital
Seoul
About this study
Official title: Influence of OATP1B1 Genotype on the Pharmacokinetics,Lipid Lowering Effect, and Lipid Profiles After Rosuvastatin Administration
This study aimed to explore the influence of organic anion transporting polypeptide1B1 (OATP1B1) genotype on pharmacokinetics, lipid lowering effect and lipid profiles after rosuvastatin administration.
Read the detailed description
Open, one arm, single sequence study for healthy volunteers are investigated. Thirty four subjects may be enrolled.
Rosuvastatin are administered once a day for 21 days. Before and after rosuvastatin administration, PK, PD and lipid profiles are investigated.
- Being tested
- Rosuvastatin
- Keywords
- OATP1B1, rosuvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
20 mg once daily for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | rosuvastatin treatment Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetic parameters(Tmax,Cmax,AUC) of rosuvastatin
Measured: Day 21 0h, 1h, 2h, 3h, 4h, 5h, 8h, 12h, 24h
Secondary outcomes (2)
lipid panel(LDL,HDL,TG,Total cholesterol)
Measured: Day 1 0h, Day 22 0h
lipid metabolites
Measured: Day -1 0h, Day21 0h, 4h, 8h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organic Anion Transporting Polypeptide1B1 (OATP1B1)Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kyung-Sang Yu, MD, PhD, Principal investigator, Seoul National University College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218347
- Sponsor's protocol ID
- SNUCPT10_Rosuvastatin_OATP1B1
- Acronym
- OATP
- Status last verified
- Jan 2011
- First submitted
- 4 Oct 2010
- Last updated
- 6 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of OATP1B1 Genotype on the Pharmacokinetics,Lipid Lowering Effect, and Lipid Profiles After Rosuvastatin Administration
- ClinicalTrials.gov ID
- NCT01218347
- Acronym / sponsor ID
- OATP / SNUCPT10_Rosuvastatin_OATP1B1
- Keywords
- OATP1B1, rosuvastatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Oct 2010 (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.
This study aimed to explore the influence of organic anion transporting polypeptide1B1 (OATP1B1) genotype on pharmacokinetics, lipid lowering effect and lipid profiles after rosuvastatin administration.
Detailed description
Open, one arm, single sequence study for healthy volunteers are investigated. Thirty four subjects may be enrolled.
Rosuvastatin are administered once a day for 21 days. Before and after rosuvastatin administration, PK, PD and lipid profiles are investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: Rosuvastatinrosuvastatin treatment |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: Between 20 to 50 years of age, inclusive (age based on the date to give the informed consent)
- Weight: Over 55 kg, within ±20% of ideal body weight
- Must be reliable and willing to make themselves available during the study period
- Must be willing to give blood sample for genotyping
Key exclusion criteria (6 listed)
- History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease
- History of a significant surgical resection of gastrointestinal tract except appendectomy
- History or evidence of drug abuse
- Use any medication during the last 14 days period before first dosing
- Hypersensitivity to HMG-CoA reductase inhibitor
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 |
|---|---|---|
| Rosuvastatin20 mg once daily for 21 days | Drug | Rosuvastatin |
Primary outcome
pharmacokinetic parameters(Tmax,Cmax,AUC) of rosuvastatin
Time frame: Day 21 0h, 1h, 2h, 3h, 4h, 5h, 8h, 12h, 24h
2 secondary outcomes
lipid panel(LDL,HDL,TG,Total cholesterol)
Time frame: Day 1 0h, Day 22 0h
lipid metabolites
Time frame: Day -1 0h, Day21 0h, 4h, 8h
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 6 Jan 2011.
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.
Kyung-Sang Yu, MD, PhD principal investigator
Seoul National University College of Medicine and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin in people with Organic Anion Transporting Polypeptide1B1 (OATP1B1) and Rosuvastatin, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 6 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 6 Jan 2011. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
pharmacokinetic parameters(Tmax,Cmax,AUC) of rosuvastatin (time frame: Day 21 0h, 1h, 2h, 3h, 4h, 5h, 8h, 12h, 24h). 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 6 Jan 2011.