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A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Abiraterone Following Administration of Abiraterone Acetate Tablets in Healthy Adult Men

23. november 2012 opdateret af: Janssen Research & Development, LLC

An Open-Label Drug-Drug Interaction Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Abiraterone (JNJ-589485) Following Administration of Abiraterone Acetate (JNJ-212082) Tablets in Healthy Male Subjects

The purpose of this study is to evaluate the pharmacokinetics, safety, and potential for drug-drug interactions when a strong inhibitor of CYP3A4 (ie, ketoconazole) is co-administered with abiraterone acetate in healthy adult men.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a non-randomized (individuals will not be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), 2-period, sequential-design, drug-drug interaction study of abiraterone acetate and ketoconazole in approximately 20 healthy adult men. This study will consist of a screening period followed by an open-label treatment phase consisting of 2 treatment periods. Successive drug administration will be separated by a washout period of at least 10 days. All individuals will receive study treatment in the same sequence. Period 1 (Days 1 to 4) consists of a single oral dose of 1000 mg abiraterone acetate tablets on Day 1 only. Period 2 (Days 11 to 17) consists of a daily oral dose of 400 mg ketoconazole tablets on Days 11 to 16 and administration of a single dose of 1000 mg abiraterone acetate on Day 14. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected at each treatment period as detailed in the protocol. Safety will be monitored continuously from the time of informed consent signing until the end of the study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

- Body mass index (BMI) between 18 and 30 kg/m2, inclusive

Exclusion Criteria:

- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Abiraterone acetate
All individuals will receive study treatment in the same sequence. Period 1 (Days 1 to 4) consists of a single oral dose of 1000 mg abiraterone acetate tablets on Day 1 only. Period 2 (Days 11 to 17) consists of a daily oral dose of 400 mg ketoconazole tablets on Days 11 to 16 and administration of a single dose of 1000 mg abiraterone acetate on Day 14.
Medicin: Period 1: Abiraterone
1000 mg abiraterone acetate tablet administered orally on Day 1
Medicin: Period 2: Abiraterone/Ketoconazole
400 mg ketoconazole tablets administered orally on Days 11 to 16
Medicin: Period 2: Abiraterone/Ketoconazole
1000 mg abiraterone acetate tablet administered orally on Day 14

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Mean plasma concentrations of abiraterone
Tidsramme: Up to Day 17
Up to Day 17
Mean plasma concentrations of ketoconazole
Tidsramme: Up to Day 14
Up to Day 14
Maximum plasma concentrations of abiraterone
Tidsramme: Up to Day 17
Up to Day 17
Time to reach the maximum plasma concentration of abiraterone
Tidsramme: Up to Day 17
Up to Day 17
Area under the plasma concentration-time curve from time 0 to time to the last quantifiable concentration of abiraterone
Tidsramme: Up to Day 17
Up to Day 17
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
Tidsramme: Up to Day 17
Up to Day 17
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone
Tidsramme: Up to Day 17
Up to Day 17
First-order rate constant associated with the terminal portion of the curve of abiraterone
Tidsramme: Up to Day 17
Up to Day 17
Time to last quantifiable plasma concentration of abiraterone
Tidsramme: Up to Day 17
Up to Day 17
Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone
Tidsramme: Up to Day 17
Up to Day 17

Sekundære resultatmål

Resultatmål
Tidsramme
The number of participants affected by an adverse event
Tidsramme: Up to end of study or early withdrawal
Up to end of study or early withdrawal

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Janssen Research & Development, LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2012

Primær færdiggørelse (Faktiske)

1. februar 2012

Studieafslutning (Faktiske)

1. februar 2012

Datoer for studieregistrering

Først indsendt

9. januar 2012

Først indsendt, der opfyldte QC-kriterier

27. april 2012

Først opslået (Skøn)

1. maj 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. november 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. november 2012

Sidst verificeret

1. november 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR100650
  • 212082PCR1002 (Anden identifikator: Janssen Research & Development, LLC)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Period 1: Abiraterone

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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