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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01080651

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Invasive Aspergillosis	Drug: Voriconazole	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

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)

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CYP2C19 extensive metabolizer	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
Active Comparator: CYP2C19 poor metabolizer	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

Arm

Intervention/Treatment

Active Comparator: CYP2C19 extensive metabolizer

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

Active Comparator: CYP2C19 poor metabolizer

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital Clinical Trial Center	Seoul		Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: In-Jin Jang, M.D., Ph.D., Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01080651

Other Study ID Numbers:

SNUCPT09_Vori2C19_B

First Posted:

Mar 4, 2010

Last Update Posted:

Aug 19, 2011

Last Verified:

Aug 1, 2011

Additional relevant MeSH terms:

Aspergillosis

Voriconazole

Study Results

No Results Posted as of Aug 19, 2011