HealthyPhase 1NCT01469416
Drug Interaction Study of Clopidogrel and Rosuvastatin
A Phase 1 study testing Rosuvastatin and Clopidogrel in people with Healthy, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to determine if clopidogrel inhibits hepatic uptake transport of rosuvastatin clinically. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rosuvastatin and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to May 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals, male or female, age 18-65 years old, with no current medical conditions or active diagnoses as determined by the study doctor based on history, physical exam and laboratory evaluations
- Subjects that take no other medications 2 weeks prior to the study and during the time course of the study including prescription medications, over-the-counter medications (except acetaminophen), dietary supplements, or drugs of abuse
- Subjects with a SLCO1B1*1A genotype
- Subjects able to maintain adequate birth control during the study independent of hormonal contraceptive use
- Subjects able to abstain from grapefruit, grapefruit juice, orange juice, caffeinated beverages and/or alcoholic beverages from 3 pm the day before the study to completion of that study day.
- Participants determined to have normal liver and kidney function as measured at baseline
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- BMI between 18.5 - 30 kg/m2
- Subjects capable of fasting from food and beverages at least 8 hours prior to medication dosing
- Be able to read, speak, and understand English
Who cannot join
- Subjects with active medical problems
- Subjects on chronic prescription or OTC medications that cannot be stopped 2 weeks prior to and during the study.
- Subjects incapable of multiple blood draws (HCT <30 mg/dL)
- Subjects with a history of rhabdomyolysis
- Subjects with a history of drug-related myalgias
- Subjects with a history or diagnosis of hemorrhagic tendencies or blood dyscrasias
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- Subjects with a history of GI bleed or peptic ulcer disease
- Subjects with a recent history of trauma
- Subjects with a recent history of or upcoming plan of surgery
- Subjects that smoke tobacco or have ongoing alcohol or illegal drug use
- Subjects who are pregnant, lactating, or trying to conceive during the study period
- Subjects allergic to rosuvastatin or clopidogrel or any known component of the medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center, UCSF
San Francisco, California, 94143
About this study
Official title: The Effects of Administering Clopidogrel on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers
The purpose of this study is to determine if clopidogrel inhibits hepatic uptake transport of rosuvastatin clinically.
- Conditions
- Healthy
- Being tested
- Rosuvastatin, Clopidogrel
- Keywords
- rosuvastatin, clopidogrel, pharmacokinetics, drug interaction, healthy volunteer, drug transporter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Rosuvastatin 20 mg PO x 1
ClopidogrelDrug
Clopidogrel 300 mg PO x 1 (30 minutes prior to rosuvastatin dose); Clopidogrel 75 mg PO x 1 (24 hours post-rosuvastatin dose)
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Active comparator | Not described Receives: Drug: Rosuvastatin |
| Rosuvastatin + clopidogrel | Experimental | Not described Receives: Drug: Rosuvastatin; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area-under-the-concentration curve (AUC) of rosuvastatin
Measured: Blood samples collected over a 48 hour period
Secondary outcomes (2)
Maximum plasma concentration (Cmax) of rosuvastatin
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 hours post-dose
Time to concentration maximum (Tmax) of rosuvastatin
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startMar 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469416
- Sponsor's protocol ID
- 11-07522
- Status last verified
- Jul 2014
- First submitted
- 28 Oct 2011
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Administering Clopidogrel on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01469416
- Acronym / sponsor ID
- 11-07522
- Conditions
- Healthy
- Keywords
- rosuvastatin, clopidogrel, pharmacokinetics, drug interaction, healthy volunteer, drug transporter
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 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.
The purpose of this study is to determine if clopidogrel inhibits hepatic uptake transport of rosuvastatin clinically.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Active comparator | Drug: Rosuvastatin |
| Rosuvastatin + clopidogrel | Experimental | Drug: Rosuvastatin, Drug: Clopidogrel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy individuals, male or female, age 18-65 years old, with no current medical conditions or active diagnoses as determined by the study doctor based on history, physical exam and laboratory evaluations
- Subjects that take no other medications 2 weeks prior to the study and during the time course of the study including prescription medications, over-the-counter medications (except acetaminophen), dietary supplements, or drugs of abuse
- Subjects with a SLCO1B1*1A genotype
- Subjects able to maintain adequate birth control during the study independent of hormonal contraceptive use
- Subjects able to abstain from grapefruit, grapefruit juice, orange juice, caffeinated beverages and/or alcoholic beverages from 3 pm the day before the study to completion of that study day.
Key exclusion criteria (12 listed)
- Subjects with active medical problems
- Subjects on chronic prescription or OTC medications that cannot be stopped 2 weeks prior to and during the study.
- Subjects incapable of multiple blood draws (HCT <30 mg/dL)
- Subjects with a history of rhabdomyolysis
- Subjects with a history of drug-related myalgias
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 |
|---|---|---|
| RosuvastatinRosuvastatin 20 mg PO x 1 | Drug | Rosuvastatin, Rosuvastatin + clopidogrel |
| ClopidogrelClopidogrel 300 mg PO x 1 (30 minutes prior to rosuvastatin dose); Clopidogrel 75 mg PO x 1 (24 hours post-rosuvastatin dose) | Drug | Rosuvastatin + clopidogrel |
Primary outcome
Area-under-the-concentration curve (AUC) of rosuvastatin
Time frame: Blood samples collected over a 48 hour period
2 secondary outcomes
Maximum plasma concentration (Cmax) of rosuvastatin
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 hours post-dose
Time to concentration maximum (Tmax) of rosuvastatin
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 hours post-dose
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 18 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Clopidogrel in people with Healthy, run by University of California, San Francisco 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 9 inclusion and 12 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 18 Jul 2014. 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?
Area-under-the-concentration curve (AUC) of rosuvastatin (time frame: Blood samples collected over a 48 hour period). 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 18 Jul 2014.