HealthyPhase 1NCT02106767
The Effects of Rifampin on the Pharmacokinetics of Rosuvastatin
A Phase 1 study testing Rosuvastatin and Rosuvastatin plus rifampin in people with Healthy, run by University of California, San Francisco at 1 site in United States.
Trial summary
The effect of transporter inhibition by rifampin on the pharmacokinetics of rosuvastatin will be studied in clinical trial in White and Asian healthy volunteers. 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 Rosuvastatin plus rifampin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 7 Aug 2016
- 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 Asian volunteers of Han-Chinese/Japanese/Korean descent whose parents and grandparents are Han-Chinese/ Japanese/ Korean.
- Healthy Caucasian volunteers of White/Caucasian/European-born descent whose parents and grandparents are White/Caucasian/European.
- Male or female, ages 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 who take no other medications two weeks prior to the study and during the time course of the study including prescription medications, over-the-counter medications, dietary supplements, or drugs of abuse.
- Subjects with the following genotype: SLCO1B1*1a and ABCG2 421CC.
- Subjects able to maintain adequate birth control during the study independent of hormonal contraceptive use.
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- Subjects able to abstain from grapefruit, grapefruit juice, oranges, orange juice, caffeinated beverages and/or alcoholic beverages from 7am the day before the study to completion of that study day.
- Participants determined to have normal liver and kidney function as measured at baseline
- BMI between 18.0 - 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.
- Subjects capable of providing informed consent and completing the requirements of the study.
Who cannot join
- Subjects with active medical problems
- Subjects on chronic prescription or OTC medication that cannot be stopped 2 weeks prior to and during the study.
- Subjects incapable of multiple blood draws (HCT < 30mg/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 who 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 rifampin or any known component of the medications
- Anyone who in the opinion of the study investigators is unable to do the study
Trial locations and contacts
1 site in 1 country.
United States1 site
CTSI Clinical Research Center, UCSF
San Francisco, California, 94143
About this study
Official title: The Effects of Single-Dose Rifampin on the Pharmacokinetics of Rosuvastatin in Healthy White and Asian Volunteers
The effect of transporter inhibition by rifampin on the pharmacokinetics of rosuvastatin will be studied in clinical trial in White and Asian healthy volunteers.
- Conditions
- Healthy
- Being tested
- Rosuvastatin, Rosuvastatin plus rifampin
- Keywords
- rosuvastatin, rifampin, pharmacokinetics, drug interaction, healthy volunteer, drug transporter, Asian, White
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
Rosuvastatin 20mg po x1
Rosuvastatin plus rifampinDrug
Also called Crestor, Rifadin, Rifampicin
Rifampin 600mg IV infused over 30 minutes followed by rosuvastatin 20mg PO x1
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Active comparator | Not described Receives: Drug: Rosuvastatin |
| Rifampin plus rosuvastatin | Experimental | Not described Receives: Drug: Rosuvastatin plus rifampin |
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: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 32, and 48 hours post-dose
Time to concentration maximum (Tmax) of rosuvastatin
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 32, 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 posted8 Apr 2014 (estimated)
- Study startNov 2014
- Primary completion7 Aug 2016
- Study completion7 Aug 2016
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie Z Benet, PhD, Principal investigator, University of California, San FranciscoLynda Frassetto, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106767
- Sponsor's protocol ID
- 14-12970
- Status last verified
- Jan 2020
- First submitted
- 3 Apr 2014
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Single-Dose Rifampin on the Pharmacokinetics of Rosuvastatin in Healthy White and Asian Volunteers
- ClinicalTrials.gov ID
- NCT02106767
- Acronym / sponsor ID
- 14-12970
- Conditions
- Healthy
- Keywords
- rosuvastatin, rifampin, pharmacokinetics, drug interaction, healthy volunteer, drug transporter, Asian, White
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 7 Aug 2016 (actual)
- Study completion
- 7 Aug 2016 (actual)
- First posted
- 8 Apr 2014 (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 effect of transporter inhibition by rifampin on the pharmacokinetics of rosuvastatin will be studied in clinical trial in White and Asian healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Active comparator | Drug: Rosuvastatin |
| Rifampin plus rosuvastatin | Experimental | Drug: Rosuvastatin plus rifampin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy Asian volunteers of Han-Chinese/Japanese/Korean descent whose parents and grandparents are Han-Chinese/ Japanese/ Korean.
- Healthy Caucasian volunteers of White/Caucasian/European-born descent whose parents and grandparents are White/Caucasian/European.
- Male or female, ages 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 who take no other medications two weeks prior to the study and during the time course of the study including prescription medications, over-the-counter medications, dietary supplements, or drugs of abuse.
- Subjects with the following genotype: SLCO1B1*1a and ABCG2 421CC.
Key exclusion criteria (11 listed)
- Subjects with active medical problems
- Subjects on chronic prescription or OTC medication that cannot be stopped 2 weeks prior to and during the study.
- Subjects incapable of multiple blood draws (HCT < 30mg/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 |
|---|---|---|
| RosuvastatinAlso: CrestorRosuvastatin 20mg po x1 | Drug | Rosuvastatin |
| Rosuvastatin plus rifampinAlso: Crestor, Rifadin, RifampicinRifampin 600mg IV infused over 30 minutes followed by rosuvastatin 20mg PO x1 | Drug | Rifampin plus rosuvastatin |
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: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 32, and 48 hours post-dose
Time to concentration maximum (Tmax) of rosuvastatin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 32, 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 23 Jan 2020.
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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.
Leslie Z Benet, PhD principal investigator
University of California, San Francisco
Lynda Frassetto, M.D. principal investigator
University of California, San Francisco
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 Rosuvastatin plus rifampin 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 12 inclusion and 11 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 23 Jan 2020. 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 23 Jan 2020.