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

Randomized, Open Clinical Trial to Evaluate Pharmacokinetic, Pharmacodynamic and Safety Profiles After Single Oral Administration of KRN1493 in Healthy Korean Male Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: KRN1493

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).

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital Clinical Trial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma KRN1493 concentration	pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours after dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma PTH concentration	pre-dose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96 hours after dosing
Albumin corrected plasma calcium concentration	pre-dose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96 hours after dosing
Plasma phosphorus concentration	pre-dose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96 hours after dosing

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Kyowa Hakko Kirin Pharma, Inc.; Jeil-Kirin Pharmaceutical Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: August 2, 2009
• First Submitted That Met QC Criteria: August 3, 2009
• First Posted (Estimate): August 4, 2009

Study Record Updates

• Last Update Posted (Estimate): August 4, 2009
• Last Update Submitted That Met QC Criteria: August 3, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Healthy volunteer
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Calcium-Regulating Hormones and Agents; Calcimimetic Agents; Cinacalcet
• Other Study ID Numbers: SNUCPT09_KRN1493