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

This study has been completed.
Sponsor:
Collaborators:
Jeil-Kirin Pharmaceutical Inc.
Kyowa Hakko Kirin Pharma, Inc.
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00952094
First received: August 2, 2009
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: KRN1493
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Open Clinical Trial to Evaluate Pharmacokinetic, Pharmacodynamic and Safety Profiles After Single Oral Administration of KRN1493 in Healthy Korean Male Subjects

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Plasma KRN1493 concentration [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours after dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma PTH concentration [ Time Frame: pre-dose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96 hours after dosing ] [ Designated as safety issue: No ]
  • Albumin corrected plasma calcium concentration [ Time Frame: pre-dose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96 hours after dosing ] [ Designated as safety issue: No ]
  • Plasma phosphorus concentration [ Time Frame: pre-dose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96 hours after dosing ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: November 2008
Study Completion Date: June 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: KRN1493 50mg group
KRN1493 50mg single oral administration
Drug: KRN1493
KRN1493 25mg tablet 2,3 or 4 tablets single oral administration
Active Comparator: KRN1493 75mg group
KRN1493 75mg single oral administration
Drug: KRN1493
KRN1493 25mg tablet 2,3 or 4 tablets single oral administration
Active Comparator: KRN1493 100mg group
KRN1493 100mg single oral administration
Drug: KRN1493
KRN1493 25mg tablet 2,3 or 4 tablets single oral administration

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).

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  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: NCT00952094

Locations
Korea, Republic of
Seoul National University Hospital Clinical Trial Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Jeil-Kirin Pharmaceutical Inc.
Kyowa Hakko Kirin Pharma, Inc.
Investigators
Principal Investigator: Kyung-Sang Yu, M.D., Ph.D. Seoul National University College of Medicine and Hospital
  More Information

No publications provided

Responsible Party: Soo-Kyung Park/Manager, Research & Development, Jeil-Kirin Pharm, Inc.
ClinicalTrials.gov Identifier: NCT00952094     History of Changes
Other Study ID Numbers: SNUCPT09_KRN1493
Study First Received: August 2, 2009
Last Updated: August 3, 2009
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Healthy volunteer

ClinicalTrials.gov processed this record on September 16, 2014