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

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: KRN1493 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Kyung-Sang Yu, M.D., Ph.D., Principal Investigator, Affiliation: Seoul National University College of Medicine and Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Plasma KRN1493 concentration

Secondary outcome:

Plasma PTH concentration

Albumin corrected plasma calcium concentration

Plasma phosphorus concentration

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

Minimum age: 20 Years. Maximum age: 35 Years. Gender(s): Male.

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

Locations and Contacts

Seoul National University Hospital Clinical Trial Center, Seoul, Korea, Republic of
Additional Information

Starting date: November 2008
Last updated: August 3, 2009

Page last updated: August 23, 2015

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