Pharmacokinetic, Pharmacodynamic and Safety Evaluation After Single Oral Administration of KRN1493

NCT ID: NCT00952094

Last Updated: 2009-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-06-30

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 before study drug administration. Subjects suitable for this study were admitted to the Clinical Trials Center, Seoul National University Hospital on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Subjects were dosed study drug orally with 240 ml water around at 9 a.m. of Day 1 and they were fasted until 4 hours post-dose. Subjects performed scheduled procedures including clinical laboratory tests, electrocardiograms and pharmacokinetic samplings. During admission, subjects were served low calcium diets. Subjects were discharged on Day 2, and visited Clinical Trials Center on Day 3, Day 4 and Day 5. Study participation was terminated on post-study visit (Day 7 - 10).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KRN1493 50mg group

KRN1493 50mg single oral administration

Group Type: ACTIVE_COMPARATOR

KRN1493

Intervention Type: DRUG

KRN1493 25mg tablet 2,3 or 4 tablets single oral administration

KRN1493 75mg group

KRN1493 75mg single oral administration

Group Type: ACTIVE_COMPARATOR

KRN1493

Intervention Type: DRUG

KRN1493 25mg tablet 2,3 or 4 tablets single oral administration

KRN1493 100mg group

KRN1493 100mg single oral administration

Group Type: ACTIVE_COMPARATOR

KRN1493

Intervention Type: DRUG

KRN1493 25mg tablet 2,3 or 4 tablets single oral administration

Interventions

KRN1493

KRN1493 25mg tablet 2,3 or 4 tablets single oral administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Jeil-Kirin Pharmaceutical Inc.

INDUSTRY

Sponsor Role: collaborator

Kyowa Hakko Kirin Pharma, Inc.

INDUSTRY

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Research & Development, Jeil-Kirin Pharm, Inc.

Principal Investigators

Kyung-Sang Yu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University College of Medicine and Hospital

Locations

Seoul National University Hospital Clinical Trial Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SNUCPT09_KRN1493

Identifier Type: -

Identifier Source: org_study_id