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

NCT01080651 | Completed Phase 1

• 1 other identifier: SNUCPT09_Vori2C19_B
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Invasive Aspergillosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

CYP2C19 extensive metabolizer

ACTIVE COMPARATOR

Drug: Voriconazole

CYP2C19 poor metabolizer

ACTIVE COMPARATOR

Drug: Voriconazole

Interventions

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

CYP2C19 extensive metabolizer; CYP2C19 poor metabolizer

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects aged 20 - 50 years.
• A body mass index (BMI) in the range 17-28 kg/m2.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Voriconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• In-Jin Jang, M.D., Ph.D.

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 4, 2010
• Study Start: December 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 19, 2011

Record last verified: 2011-08

Locations

KR (1)