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

Invasive Aspergillosis Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080651
• Other study ID #: SNUCPT09_Vori2C19_B
• Status: Completed
• Phase: Phase 1
• First received: March 2, 2010
• Last updated: August 17, 2011
• Start date: December 2008
• Est. completion date: March 2009

Study information

• Verified date: August 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Aspergillosis
• Invasive Aspergillosis

Intervention

Drug:
• Voriconazole
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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital Clinical Trial Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No