NCT00716846

Brief Summary

The purpose of this study is to investigate whether statins have any influence on cytochrome P450 (CYP) 3A4 enzyme activity using a probe drug midazolam.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable healthy-volunteers

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

Study Start

First participant enrolled

June 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

September 7, 2011

Status Verified

March 1, 2009

Enrollment Period

2.1 years

First QC Date

July 10, 2008

Last Update Submit

September 5, 2011

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • the pharmacokinetics of oral midazolam

    after 14-days treatment with statins

Study Arms (3)

statin-1

ACTIVE COMPARATOR

simvastatin

Drug: simvastatin

statin-2

ACTIVE COMPARATOR

atorvastatin

Drug: atorvastatin

statin-3

ACTIVE COMPARATOR

pitavastatin

Drug: pitavastatin

Interventions

simvastatinDRUG

10mg, 2 weeks

Also known as: Lipovas tablets
statin-1
atorvastatinDRUG

10mg

Also known as: Lipitor tablets
statin-2
pitavastatinDRUG

2mg

Also known as: Livalo tablets
statin-3

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers in good health according to their medical history, a physical examination and standard laboratory tests

You may not qualify if:

  • Subjects who have been using any continuous medication or herbal supplements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamamatsu University School of Medicine

Hamamatsu, Japan

Location

MeSH Terms

Interventions

SimvastatinAtorvastatinpitavastatin

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Hiroshi Watanabe, MD,PhD

    Hamamatsu University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacology and Therapeutics

Study Record Dates

First Submitted

July 10, 2008

First Posted

July 16, 2008

Study Start

June 1, 2006

Primary Completion

July 1, 2008

Study Completion

August 1, 2008

Last Updated

September 7, 2011

Record last verified: 2009-03

Locations

JP(1)