Status:
COMPLETED
Pharmacokinetic, Pharmacodynamic and Safety Evaluation After Single Oral Administration of KRN1493
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Jeil-Kirin Pharmaceutical Inc.
Kyowa Hakko Kirin Pharma, Inc.
Conditions:
Healthy
Eligibility:
MALE
20-35 years
Phase:
PHASE1
Brief Summary
Randomized, open, single ascending dose, parallel study to evaluate the pharmacokinetics, pharmacodynamics and safety of KRN1493 after single oral administration in healthy Korean male volunteers.
Detailed Description
Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 3 weeks bef...
Eligibility Criteria
Inclusion
- Healthy male subjects aged 20 - 35 years
- A body mass index (BMI) in the range 19-27 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.
- Subject who didn't drink grapefruit within 3 days prior to the test drug dosing
- Subject judged eligible for study participation by investigator considering screening result except PTH
Exclusion
- Clinically relevant abnormal medical history that could interfere with the objectives of the study.
- 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.
- Presence or history of severe adverse reaction to any drug or a history of severe allergic disease.
- Presence or history of drug or alcohol abuse.
- Participation in other clinical trial within 3 months (in case of bioequivalence study or other clinical trial) or within 4 months (in case of phase 1 study) or with 1 month (in case of patch) prior to scheduled study drug administration (measured from the final dosing day in the previous trial)
- Use of a prescription medicine, herbal medicine or over-the-counter medication within 7 days before first dose
- Use of medication or food which induces or inhibits CYP2D6 or CYP3A4 within 1 month prior to the test drug dosing (except food contain grapefruit)
- Loss of more than 400 mL blood during the 3 months or 200ml during the 1 month before the study, or apheresis during 2 weeks before the study.
- Subject judged not eligible for study participation by investigator
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00952094
Start Date
November 1 2008
End Date
June 1 2009
Last Update
August 4 2009
Active Locations (1)
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1
Seoul National University Hospital Clinical Trial Center
Seoul, South Korea