- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01575587
A Study to Assess the Effect of Timing of Food Intake on the Pharmacokinetics of Abiraterone Following Single-Dose Administration of Abiraterone Acetate Tablets in Healthy Caucasian and Japanese Men
9. januar 2014 oppdatert av: Janssen Research & Development, LLC
A Single-Dose, Open-Label, Randomized, 4-Way Crossover Study to Assess the Effect of Timing of Food Intake on the Pharmacokinetics of Abiraterone Following Single-Dose Administration of Abiraterone Acetate Tablets in Healthy Caucasian and Japanese Male Subjects
The purpose of this study is to evaluate the effect of timing of food intake on systemic abiraterone exposure observed in healthy adult Japanese and Caucasian men.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
This is a randomized (individuals will be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), single dose, 4-way crossover study of abiraterone acetate in approximately 48 healthy adult Japanese and Caucasian men.
For the crossover design, the treatment sequences are defined as follows: 1 - ADBC, 2 - BACD, 3 - CBDA, and 4 - DCAB; where Treatment A = abiraterone acetate administered in the fasted state, Treatment B = standardized meal administered 1 hour after abiraterone acetate dose, Treatment C = standardized meal administered 2 hours after abiraterone acetate dose, and Treatment D = standardized meal administered 2 hours before and 2 hours after abiraterone acetate dose.
This study will consist of a screening period followed by four open-label treatment periods separated by a washout period of at least 14 days between dosing.
Eligible participants will be randomly assigned on Day 1 to 1 of 4 treatment sequences that differ with regard to timing of food intake before and/or after dosing with a single dose of 1000 mg of abiraterone acetate.
Serial pharmacokinetic (study of what the body does to a drug) samples will be collected during the open-label treatment phase as detailed in the protocol.
Safety will be monitored throughout the study.
End-of-study assessments will be performed on Day 4 of Period 4 or upon early withdrawal.
Studietype
Intervensjonell
Registrering (Faktiske)
51
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
Cypress, California, Forente stater
-
-
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
25 år til 35 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Healthy Caucasian and Japanese male individuals.
- Body mass index between 18 and 30 kg/m2.
- Body weight >=50 kg.
- A normal 12-lead electrocardiogram.
Exclusion Criteria:
- History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results.
- Presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc.) or any medical condition that would affect sexual function.
- History of alcohol consumption of more than 4 drinks daily within 1 year prior to screening and unwillingness to abstain from alcohol-containing food or beverages from within 24 hours before Day-1 through study completion.
- History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years.
- Positive test for human immunodeficiency virus 1 and 2 antibodies, hepatitis B surface antigen, or hepatitis C antibodies.
- History of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or participant's verbal report.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Behandling B
|
Standardized meal administered 1 hour after the 1000 mg abiraterone acetate dose
|
Eksperimentell: Behandling C
|
Standardized meal administered 2 hours before the 1000 mg abiraterone acetate dose
|
Eksperimentell: Behandling A
|
1000 mg abiraterone acetate administered in the fasting state
|
Eksperimentell: Behandling D
|
Standardized meal administered 2 hours before and 2 hours after the 1000 mg abiraterone acetate dose
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Changes in mean plasma concentrations of abiraterone
Tidsramme: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Mean plasma concentrations of abiraterone
Tidsramme: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
Maximum plasma concentration of abiraterone
Tidsramme: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
Time to reach the maximum plasma concentration of abiraterone
Tidsramme: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentration of abiraterone
Tidsramme: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
Tidsramme: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone
Tidsramme: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
First-order rate constant associated with the terminal portion of the curve of abiraterone
Tidsramme: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
Time to last quantifiable plasma concentration of abiraterone
Tidsramme: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone
Tidsramme: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
The number of participants affected by an adverse event
Tidsramme: Up to the end of the study (4 days after final dose of study drug) or early withdrawal
|
Up to the end of the study (4 days after final dose of study drug) or early withdrawal
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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
1. januar 2012
Primær fullføring (Faktiske)
1. mai 2012
Studiet fullført (Faktiske)
1. mai 2012
Datoer for studieregistrering
Først innsendt
19. januar 2012
Først innsendt som oppfylte QC-kriteriene
10. april 2012
Først lagt ut (Anslag)
11. april 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
10. januar 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. januar 2014
Sist bekreftet
1. januar 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- CR100737
- 212082PCR1005 (Annen identifikator: Janssen Research & Development, LLC)
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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