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

Phase 1

Completed

• Conditions: Invasive Aspergillosis
• Interventions: Drug: Voriconazole

• Registration Number: NCT01080651
• Lead Sponsor: Seoul National University Hospital

Brief Summary

To evaluate the drug-drug interaction between rifampicin and voriconazole according to CYP2C19 genotype quantitatively following a single oral administration of 200 mg voriconazole

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2010-03-02
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-04
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-17
• Last Update Posted: 2011-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CYP2C19 poor metabolizer	Voriconazole	-
CYP2C19 extensive metabolizer	Voriconazole	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital Clinical Trial Center; 🇰🇷 Seoul, Korea, Republic of