- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
46
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Texas
-
Austin, Texas, Förenta staterna, 78744
- GSK Investigational Site
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 45 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Area under the curve, half life
Tidsram: 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
Tidsram: Day 1-11
|
Day 1-11
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
12 lead ECGs, safety labs, vital signs, heart rate, blood pressure
Tidsram: Day 1- Day 11 of the study
|
Day 1- Day 11 of the study
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
12 december 2011
Primärt slutförande (Faktisk)
9 februari 2012
Avslutad studie (Faktisk)
9 februari 2012
Studieregistreringsdatum
Först inskickad
14 juni 2012
Först inskickad som uppfyllde QC-kriterierna
21 juni 2012
Första postat (Uppskatta)
26 juni 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 juni 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 juni 2017
Senast verifierad
1 juni 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Graviditetskomplikationer
- Obstetriska förlossningskomplikationer
- Obstetrisk förlossning, för tidigt
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Enzyminhibitorer
- Hormoner, hormonsubstitut och hormonantagonister
- Cytokrom P-450 CYP3A-hämmare
- Cytokrom P-450 enzymhämmare
- Hormonantagonister
- Antifungala medel
- Steroidsyntesinhibitorer
- 14-alfa-demetylasinhibitorer
- Ketokonazol
Andra studie-ID-nummer
- 115893
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokument
-
Klinisk studierapport
Informationsidentifierare: 115893Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Informerat samtycke
Informationsidentifierare: 115893Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datauppsättningsspecifikation
Informationsidentifierare: 115893Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Annoterad fallrapportformulär
Informationsidentifierare: 115893Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistisk analysplan
Informationsidentifierare: 115893Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Studieprotokoll
Informationsidentifierare: 115893Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datauppsättning för individuella deltagare
Informationsidentifierare: 115893Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .