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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Dermatomycoses
Hyalohyphomycosis
Infection
Mycoses
Skin Diseases
Skin Diseases, Infectious
Voriconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014