- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00501397
A Study of the Effects of Ketoconazole Taken Orally Has on the PK Profiles of a Dose of GSK189075 in Healthy Volunteers
31. maj 2012 opdateret af: GlaxoSmithKline
An Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole on the Pharmacokinetics of GSK189075
The purpose of this research study is to evaluate the effect of several daily doses of ketoconazole (a medication used to treat fungal infections like athlete's foot) on a single dose of GSK189075 (an experimental diabetes drug), and also to evaluate the safety and tolerability of GSK189075 in healthy volunteers.
The study will see whether ketoconazole causes GSK189075 to stay in your bloodstream for a longer period of time.
It will also examine whether GSK189075 causes any changes in the amount of glucose you have in your urine.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
22
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ohio
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Columbus, Ohio, Forenede Stater, 43212
- GSK Investigational Site
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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
18 år til 55 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Are a healthy, non-smoking male or female.
- Are 18 to 55 years old, inclusive.
- Have a body weight of > or equal to 110 pounds.
- Are a female who is unable to have any more children and have a negative pregnancy test.
- Are willing and able to provide written informed consent before the start of any study-related procedures.
- Are able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions.
Exclusion Criteria:
- Smoke or use any tobacco products.
- Have a known allergic reaction to ketoconazole or study drug.
- Have a history of regular alcohol consumption greater than 7 drinks per week for females or greater than 14 drinks per week for males.
- Have a positive drug or alcohol or smoking test at screening or check-in to the clinic.
- Have participated in another clinical trial within 30 days prior to screening in which you have received an investigational drug.
- Have donated a pint of blood within 56 days before the first dose of study drug.
- Have any known or suspected stomach condition (or stomach surgery within the 6 months prior to dosing).
- Have abnormal liver test results.
- Have a documented history or diagnosis of cirrhosis.
- Have positive results for hepatitis C or B, or HIV at screening.
- Have blood pressure outside of the normal range.
- Are a male subject who is unwilling to either abstain from sexual activity or unwilling to use birth control during the course of the study.
- Are using non-prescription drugs, vitamins, herbal or dietary supplements (including St John's Wort) within 7 days before the first dose of study medication,
- Have any abnormality identified on the screening physical or laboratory examination that the study physician feels would make it inappropriate for you to participate in the study.
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: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Plasma blood samples for GSK189075 at Day 1 Session 1, Days 5 & 6 Session 3
Tidsramme: at Day 1 Session 1, Days 5 & 6 Session 3 urine collections for volume
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at Day 1 Session 1, Days 5 & 6 Session 3 urine collections for volume
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urine collections for volume, glucose, & creatinine at Day 1 Session 1, Days 5 & 6 Session 3.
Tidsramme: at Day 1 Session 1, Days 5 & 6 Session 3.
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at Day 1 Session 1, Days 5 & 6 Session 3.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Adverse events: all visits
Tidsramme: all visits
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all visits
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ECG,labs: Screening,Days -1 & 1 Session 1,Day 4 Session 2,Days 5-6 Session 3
Tidsramme: Screening,Days -1 & 1 Session 1,Day 4 Session 2,Days 5-6 Session 3
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Screening,Days -1 & 1 Session 1,Day 4 Session 2,Days 5-6 Session 3
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Labs:followup
Tidsramme: followup
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followup
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Urine: Day 1 Session 1,Days 5-6 Session 3
Tidsramme: Day 1 Session 1,Days 5-6 Session 3
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Day 1 Session 1,Days 5-6 Session 3
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Vitals: Screening,Days -1 & 1 Session 1,Days 1-4 Session 2,Days 5-6 Session 3,followup
Tidsramme: Screening,Days -1 & 1 Session 1,Days 1-4 Session 2,Days 5-6 Session 3,followup
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Screening,Days -1 & 1 Session 1,Days 1-4 Session 2,Days 5-6 Session 3,followup
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. februar 2007
Datoer for studieregistrering
Først indsendt
13. juli 2007
Først indsendt, der opfyldte QC-kriterier
13. juli 2007
Først opslået (Skøn)
16. juli 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. juni 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. maj 2012
Sidst verificeret
1. februar 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdomme i det endokrine system
- Diabetes mellitus
- Diabetes mellitus, type 2
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Enzymhæmmere
- Hormoner, hormonsubstitutter og hormonantagonister
- Cytokrom P-450 CYP3A-hæmmere
- Cytokrom P-450 enzymhæmmere
- Hormonantagonister
- Antifungale midler
- Steroidsyntesehæmmere
- 14-alfa-demethylasehæmmere
- Ketoconazol
Andre undersøgelses-id-numre
- KG2108197
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 .
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