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

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

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Key information

Conditions

Invasive Aspergillosis

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

Plasma concentration of voriconazole

Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Clinical Trials to Evaluate the Influence of CYP2C19 Genotype and Drug-drug Interactions on the Pharmacokinetics of Voriconazole in Healthy Korean Male Volunteers (Part B)

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Mar 4, 2010
Registry last updated: Aug 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed