NCT02106767

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2016

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

1.8 years

First QC Date

April 3, 2014

Last Update Submit

January 21, 2020

Conditions

Healthy

Keywords

rosuvastatinrifampinpharmacokineticsdrug interactionhealthy volunteerdrug transporterAsianWhite

Outcome Measures

Primary Outcomes (1)

  • Area-under-the-concentration curve (AUC) of rosuvastatin

    Blood samples collected over a 48 hour period

Secondary Outcomes (2)

  • Maximum plasma concentration (Cmax) of rosuvastatin

    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

    0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 32, and 48 hours post-dose

Study Arms (2)

Rosuvastatin

ACTIVE COMPARATOR
Drug: Rosuvastatin

Rifampin plus rosuvastatin

EXPERIMENTAL
Drug: Rosuvastatin plus rifampin

Interventions

RosuvastatinDRUG

Rosuvastatin 20mg po x1

Also known as: Crestor
Rosuvastatin
Rosuvastatin plus rifampinDRUG

Rifampin 600mg IV infused over 30 minutes followed by rosuvastatin 20mg PO x1

Also known as: Crestor, Rifadin, Rifampicin
Rifampin plus rosuvastatin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CTSI Clinical Research Center, UCSF

San Francisco, California, 94143, United States

Location

MeSH Terms

Interventions

Rosuvastatin CalciumRifampin

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Leslie Z Benet, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Lynda Frassetto, M.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 8, 2014

Study Start

November 1, 2014

Primary Completion

August 7, 2016

Study Completion

August 7, 2016

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations

US(1)