NCT00952094

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 2008

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
Last Updated

August 4, 2009

Status Verified

August 1, 2009

Enrollment Period

2 months

First QC Date

August 2, 2009

Last Update Submit

August 3, 2009

Conditions

Healthy

Keywords

Healthy volunteer

Outcome Measures

Primary Outcomes (1)

  • Plasma KRN1493 concentration

    pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours after dosing

Secondary Outcomes (3)

  • 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

Study Arms (3)

KRN1493 50mg group

ACTIVE COMPARATOR

KRN1493 50mg single oral administration

Drug: KRN1493

KRN1493 75mg group

ACTIVE COMPARATOR

KRN1493 75mg single oral administration

Drug: KRN1493

KRN1493 100mg group

ACTIVE COMPARATOR

KRN1493 100mg single oral administration

Drug: KRN1493

Interventions

KRN1493DRUG

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

KRN1493 100mg groupKRN1493 50mg groupKRN1493 75mg group

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

Location

Study Officials

  • Kyung-Sang Yu, M.D., Ph.D.

    Seoul National University College of Medicine and Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2009

First Posted

August 4, 2009

Study Start

November 1, 2008

Primary Completion

January 1, 2009

Study Completion

June 1, 2009

Last Updated

August 4, 2009

Record last verified: 2009-08

Locations

KR(1)