Clinical trial NCT00952094: Pharmacokinetic, Pharmacodynamic and Safety Evaluation After Single Oral Administration of KRN1493
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Jeil-Kirin Pharmaceutical Inc.
name: Kyowa Hakko Kirin Pharma, Inc.
First posted: 2009-08-04
Enrollment: 39
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Plasma KRN1493 concentration
timeFrame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours after dosing
Secondary outcomes:
measure: Plasma PTH concentration
timeFrame: pre-dose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96 hours after dosing
measure: Albumin corrected plasma calcium concentration
timeFrame: pre-dose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96 hours after dosing
measure: Plasma phosphorus concentration
timeFrame: pre-dose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96 hours after dosing
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Clinical Trial Center
Study officials:
affiliation: Seoul National University College of Medicine and Hospital
name: Kyung-Sang Yu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: