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- Klinische proef NCT00915434
A Study to Characterize the Pharmacokinetics and Effect of Food on JNJ-31001074 in Healthy Volunteers
22 april 2010 bijgewerkt door: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Single-Dose, Open-Label, Randomized, 4-Way Crossover Study to Characterize the Pharmacokinetics and the Effect of Food of JNJ-31001074 in Healthy Subjects
This is an open-label (both the physician and healthy volunteer know which treatment will be administered), single-dose, 4-period study to characterize the pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) and effect of food on the pharmacokinetics of JNJ-31001074.
The study consists of three phases: a screening phase to determine eligibility, an open-label 4-period treatment phase and an end-of-study/early withdrawal assessment phase.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This is an open-label (both the physician and healthy volunteer know which treatment will be administered), randomized (treatment order determined by chance), single-dose study to characterize the pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) and effect of food on the pharmacokinetics of JNJ-31001074.
The study consists of three phases: a screening phase to determine eligibility, an open-label treatment phase and an end-of-study/early withdrawal assessment phase.
During the screening phase, healthy volunteers will be evaluated to see if they meet selection criteria as specified in the protocol.
Healthy volunteers who meet these criteria will report to the study center on Day -1 to begin treatment.
The open-label treatment phase will consist of 4 periods.
In each period, volunteers will receive one of the following treatments: Treatment A 1 mg JNJ-31001074, Treatment B 3 mg JNJ-31001074, Treatment C 10 mg JNJ-31001074, and Treatment D 10 mg JNJ-31001074.
Treatment A, B and C will be administered under fasting conditions (no food or beverages for 10 hours prior to dosing) and Treatment D will be administered after a high-fat meal.
The order in which volunteers will receive each treatment will be determined in a random fashion (like flipping a coin).
Each treatment will be separated by a 7-14 day washout period.
Multiple blood and urine samples will be collected for 72 hours after each dose.
Safety and tolerability will be assessed throughout the volunteer's participation.
Volunteers will be instructed to report any adverse events that occur up to 30 days after their last dose of study drug.
The maximum study duration for each volunteer is expected to be 66 days.
JNJ-31001074 1, 3 or 10 mg will be administered orally on Day 1 of each of the 4 treatment periods (dose depends on participant's treatment sequence)
Studietype
Ingrijpend
Inschrijving (Werkelijk)
20
Fase
- Fase 1
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 55 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Healthy volunteer between the ages of 18-55
- if a woman, must be of non childbearing potential (ie, post menopausal or surgically sterile) and have a negative pregnancy test
- body mass index between 18-30
- body weight greater than or equal to 50 kilograms
- blood pressure between 90 and 140 mgHg systolic and no higher than 90 mgHg diastolic
- nonsmoker
Exclusion Criteria:
- History of or current clinically significant medical illness
- clinically significant abnormal laboratory value(s)
- clinically significant abnormal physical examination, vital signs or electrocardiogram
- pregnant, lactating or completed last term pregnancy within six months of screening
- use of any prescription or non prescription medication except for paracetamol (acetaminophen/TYLENOL)
- history of drug or alcohol abuse
- history of smoking or use of nicotine-containing substances within the previous two months
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
To characterize the pharmacokinetics of JNJ-31001074 after single-dose administration of 1, 3 and 10 mg JNJ-31001074 and to quantify the effect of food on the pharmacokinetics of 10 mg JNJ-31001074.
Tijdsspanne: Multiple blood and urine samples will be collected for 72 hours after dosing of JNJ-31001074 in each of the 4 treatment periods
|
Multiple blood and urine samples will be collected for 72 hours after dosing of JNJ-31001074 in each of the 4 treatment periods
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
To evaluate the safety and tolerability of JNJ-31001074
Tijdsspanne: up to 66 days (including 21 day screening period)
|
up to 66 days (including 21 day screening period)
|
|
To assess pharmacokinetic dose proportionality of JNJ-31001074 after single-dose administration of 1, 3 and 10 mg
Tijdsspanne: up to 66 days (including 21 day screening period)
|
up to 66 days (including 21 day screening period)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2009
Studie voltooiing (Werkelijk)
1 november 2009
Studieregistratiedata
Eerst ingediend
4 juni 2009
Eerst ingediend dat voldeed aan de QC-criteria
4 juni 2009
Eerst geplaatst (Schatting)
8 juni 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
26 april 2010
Laatste update ingediend die voldeed aan QC-criteria
22 april 2010
Laatst geverifieerd
1 april 2010
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- CR016180
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .