- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00915434
A Study to Characterize the Pharmacokinetics and Effect of Food on JNJ-31001074 in Healthy Volunteers
22. april 2010 oppdatert av: 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.
Studieoversikt
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
20
Fase
- Fase 1
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 55 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
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.
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To evaluate the safety and tolerability of JNJ-31001074
Tidsramme: 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
Tidsramme: up to 66 days (including 21 day screening period)
|
up to 66 days (including 21 day screening period)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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
1. juni 2009
Studiet fullført (Faktiske)
1. november 2009
Datoer for studieregistrering
Først innsendt
4. juni 2009
Først innsendt som oppfylte QC-kriteriene
4. juni 2009
Først lagt ut (Anslag)
8. juni 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
26. april 2010
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. april 2010
Sist bekreftet
1. april 2010
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- CR016180
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. .
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