Influence of Drug-drug Interactions on the Pharmacokineti... | NCT01080651

Studies
Influence of Drug-drug Interactions on the Pharmacokinetics (PK) of Voriconazole

NCT01080651

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Aug 19, 2011Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Invasive Aspergillosis

Interventions

Voriconazole

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Mar 2, 2010

First Submission Date that Met QC Criteria

Mar 2, 2010

First Posted Date

Mar 4, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2011

Last Update Posted Date

Aug 19, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CYP2C19 extensive metabolizer	Active Comparator		Drug: Voriconazole
CYP2C19 poor metabolizer	Active Comparator		Drug: Voriconazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Voriconazole	Drug	Day1: voriconazole 200 mg x 2, oral administration, Day2-7: rifampin 600 mg, once a day oral administration, Day8: voriconazole 200 mg x 2 + rifampin 600 mg, oral co-administration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma concentration of voriconazole	Sample for concentration measurement conducted before and after rifampicin treatment as same manner	pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h post-dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1.Healthy male subjects aged 20 - 50 years.
2.A body mass index (BMI) in the range 17-28 kg/m2.
3.Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully informed about the study procedures.

Exclusion Criteria:

1.Presence or history of severe adverse reaction to any drug or a history of severe allergic disease.
2.Clinically relevant abnormal medical history that could interfere with the objectives of the study.
3.Presence or history of eye disease or eye field defect.
4.A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug.
5.A subject whose liver function test (AST, ALT, GGT, ALP, LDH) result is over 1.25 times of upper limit of normal range.
6.A subject whose SBP is over 140 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
7.Presence or history of drug abuse.
8.Participation in other clinical trial within 2 months.
9.Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication within 1 week before first dose.
10.Blood donation during 2 months or apheresis during 1 month before the study.
11.Presence or history of alcohol abuse.
12.Smoking of more than 10 cigarettes/day.
13.Use of grapefruit juice, xanthine containing beverage, alcohol or smoking during restriction period.
14.Subject judged not eligible for study participation by investigator.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds