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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01080651
First received: March 2, 2010
Last updated: August 17, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Invasive Aspergillosis
Drug: Voriconazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Plasma concentration of voriconazole [ Time Frame: pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h post-dose ] [ Designated as safety issue: No ]
    Sample for concentration measurement conducted before and after rifampicin treatment as same manner


Enrollment: 12
Study Start Date: December 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080651

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: In-Jin Jang, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01080651     History of Changes
Other Study ID Numbers: SNUCPT09_Vori2C19_B
Study First Received: March 2, 2010
Last Updated: August 17, 2011
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Aspergillosis
Mycoses
Voriconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 22, 2014