- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01627587
A Two Cohort Study to Look at the Metabolites of GSK221149, the Metabolism of GSK221149 Administered With a High Fat Meal and With Ketoconazole
13. juni 2017 oppdatert av: GlaxoSmithKline
A Two Cohort, Open-label Study to Evaluate the Pharmacokinetics of GSK2847065, the Metabolite of Retosiban (GSK221149) After Single and Repeat Oral Doses, the Pharmacokinetics of GSK221149 Coadministered With a High Fat Meal, and the Pharmacokinetics of GSK221149 Coadministered With an Inhibitor of CYP3A4 (Ketoconazole)
This is a two part study.
Part A of the study will evaluate the metabolites of GSK221149 following single and repeat oral dosing and will also assess the pharmacokinetics of GSK221149 when administered with a potent CYP3A4 inhibitor Ketoconazole.
Part B of the study will look at the pharmacokinetics of GSK221149 following a high fat meal.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
46
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Texas
-
Austin, Texas, Forente stater, 78744
- GSK Investigational Site
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 45 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- ALT, alkaline phosphatase and bilirubin less than and equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%).
- Single [QTc, QTcB or QTcF] less than 450 msec; or QTc less than 480 msec in subjects with Bundle Branch Block.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Female subjects between 18 and 45 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of: Child-bearing potential and is abstinent or agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 48 hours post last dose.
- Body weight greater than 50 kg and BMI within the range 19-29.9 kg/m2 (inclusive).
Exclusion Criteria:
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol/urine cotinine screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of greater than 7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive serum hCG test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummels, exotic citrus fruits, grapefruit hybrids from 7 days prior to the first dose of study medication.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Ketoconazole-Part A
Healthy Female volunteers of child bearing potential will receive Treatment A, B and C
|
Treatment A: 750 mg GSK221149 single dose
Treatment B: 400 mg of Ketoconazole single dose
Treatment C: 100mg of GSK221149 single dose
|
|
Eksperimentell: Food-Part B
Healthy Female Volunteers of child bearing potential will receive Treament D and E
|
Treatment D: 750 mg of GSK221149 administered fasted
Treatment E: 750 mg of GSK221149 administered with a high fat meal
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Area under the curve, half life
Tidsramme: From Day 1- Day 11 of the study
|
From Day 1- Day 11 of the study
|
|
Area under the curve, half life, when treate with ketconizole
Tidsramme: Day 1-11
|
Day 1-11
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
12 lead ECGs, safety labs, vital signs, heart rate, blood pressure
Tidsramme: Day 1- Day 11 of the study
|
Day 1- Day 11 of the study
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
12. desember 2011
Primær fullføring (Faktiske)
9. februar 2012
Studiet fullført (Faktiske)
9. februar 2012
Datoer for studieregistrering
Først innsendt
14. juni 2012
Først innsendt som oppfylte QC-kriteriene
21. juni 2012
Først lagt ut (Anslag)
26. juni 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. juni 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. juni 2017
Sist bekreftet
1. juni 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Graviditetskomplikasjoner
- Obstetriske arbeidskomplikasjoner
- Obstetrisk arbeid, prematur
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Enzymhemmere
- Hormoner, hormonsubstitutter og hormonantagonister
- Cytokrom P-450 CYP3A-hemmere
- Cytokrom P-450 enzymhemmere
- Hormonantagonister
- Antifungale midler
- Steroidesyntesehemmere
- 14-alfa-demetylasehemmere
- Ketokonazol
Andre studie-ID-numre
- 115893
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokumenter
-
Klinisk studierapport
Informasjonsidentifikator: 115893Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Skjema for informert samtykke
Informasjonsidentifikator: 115893Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datasettspesifikasjon
Informasjonsidentifikator: 115893Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Annotert saksrapportskjema
Informasjonsidentifikator: 115893Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistisk analyseplan
Informasjonsidentifikator: 115893Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Studieprotokoll
Informasjonsidentifikator: 115893Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datasett for individuell deltaker
Informasjonsidentifikator: 115893Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .