- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00952094
Pharmacokinetic, Pharmacodynamic and Safety Evaluation After Single Oral Administration of KRN1493
3. august 2009 opdateret af: Seoul National University Hospital
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.
Studieoversigt
Detaljeret beskrivelse
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).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
39
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Seoul, Korea, Republikken
- Seoul National University Hospital Clinical Trial Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 35 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: KRN1493 50mg group
KRN1493 50mg single oral administration
|
KRN1493 25mg tablet 2,3 or 4 tablets single oral administration
|
|
Aktiv komparator: KRN1493 75mg group
KRN1493 75mg single oral administration
|
KRN1493 25mg tablet 2,3 or 4 tablets single oral administration
|
|
Aktiv komparator: KRN1493 100mg group
KRN1493 100mg single oral administration
|
KRN1493 25mg tablet 2,3 or 4 tablets single oral administration
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Plasma KRN1493 concentration
Tidsramme: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours after dosing
|
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours after dosing
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Plasma PTH concentration
Tidsramme: pre-dose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96 hours after dosing
|
pre-dose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96 hours after dosing
|
|
Albumin corrected plasma calcium concentration
Tidsramme: pre-dose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96 hours after dosing
|
pre-dose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96 hours after dosing
|
|
Plasma phosphorus concentration
Tidsramme: pre-dose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96 hours after dosing
|
pre-dose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96 hours after dosing
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2008
Primær færdiggørelse (Faktiske)
1. januar 2009
Studieafslutning (Faktiske)
1. juni 2009
Datoer for studieregistrering
Først indsendt
2. august 2009
Først indsendt, der opfyldte QC-kriterier
3. august 2009
Først opslået (Skøn)
4. august 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. august 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. august 2009
Sidst verificeret
1. august 2009
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SNUCPT09_KRN1493
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .