- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01516047
A Pharmacokinetic Study of Abiraterone Acetate in Patients With Severe Hepatic Impairment Compared to Patients With Normal Hepatic Function
24. juni 2014 opdateret af: Janssen Research & Development, LLC
An Open-Label Pharmacokinetic Study of Abiraterone Acetate Suspension in Subjects With Severe Hepatic Impairment Compared to Matched Control Subjects With Normal Hepatic Function
The purpose of this study is to evaluate systemic exposure of abiraterone acetate in adult male patients with severe hepatic impairment and is being conducted to collect information that will support clinical dosing recommendations for this subpopulation.
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), single dose, 2-cohort study of abiraterone acetate in approximately 16 adult men.
Participants will either have severe hepatic impairment (Cohort 1) or qualify for the control group with normal hepatic function (Cohort 2).
This study will consist of a screening period followed by a 4-day open-label treatment phase and subsequently a 28-day follow up after the study dose of abiraterone acetate suspension.
Patients will be admitted to the study center on Day -1, a single dose of study drug will be administered on the morning of Day 1, and patients will remain at the study center until completion of the 72-hour pharmacokinetic (PK; study of what the body does to a drug) blood sample collection in the morning of Day 4. Enrollment will begin sequentially with patients in the severe hepatic impairment cohort.
Enrollment for Cohort 1 will be staggered in order to evaluate safety and tolerability.
The study will not proceed if >=Grade 3 toxicity or serious adverse events considered related to abiraterone acetate are observed.
Additional patients may be enrolled if at least 8 patients in each cohort do not complete the required assessments, including the PK blood sample collections.
The aim will be to treat the remaining patients in Cohort 1 at a suspension dose yielding an exposure equivalent to 1000 mg tablet in healthy individuals.
If the dose is adjusted after Study Evaluation Team review, additional patients may be enrolled to ensure at least 8 patients complete the study at the final dose.
Once enrollment of patients in the severe hepatic impairment cohort is completed, the matched-control cohort will be dosed.
Serial PK samples will be collected during the open-label treatment phase as detailed in the protocol.
Safety will be monitored throughout the study.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
16
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Anaheim, California, Forenede Stater
-
-
Florida
-
Orlando, Florida, Forenede Stater
-
-
Texas
-
San Antonio, Texas, Forenede Stater
-
-
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
35 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- All participants are to be cancer free and have a body mass index (BMI) between 18 kg/m2 to 40 kg/m2, inclusive, and body weight not less than 50 kg.
- Cohort 1is characterized by severe hepatic impairment (as described by the Child-Pugh Classification C).
- Cohort 2 represents a matched control characterized by healthy participants with normal hepatic function.
- Control cohort participants will be age matched ± 10 years and BMI matched within 20% of the means of the severe hepatic impairment cohort; no other clinical criteria will be matched.
- Control cohort participants must be in good health, with no clinically significant findings from medical history, physical examination, laboratory evaluations, 12-lead electrocardiogram and vital signs.
- Patients with hepatic impairment are required to be on medication and/or treatment regimen to treat their underlying hepatic impairment or medical conditions before dosing with study drug.
Exclusion Criteria:
- Participants in the control cohort who test positive for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies will not be permitted to enroll in the study.
- Patients with hepatic impairment who have acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment in the judgment of either the investigator or the sponsor's medical monitor will be excluded from participating in the study.
- Patients with hepatic impairment taking antiviral therapy for treatment of active hepatitis infection at the time of screening, previously diagnosed with hepatocellular carcinoma, or who have a history of biliary sepsis within the past 2 years.
- Patients with severe hepatic impairment should not have Gilbert's syndrome or >= Grade 3 hepatic encephalopathy where the patient lacks the capacity to provide informed consent as judged by the investigator. Mild or moderate hepatic encephalopathy that would not impede informed consent in the investigator's judgment is permitted.
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: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Cohort 1
Patients with severe hepatic impairment.
|
125 mg to 2000 mg abiraterone acetate suspension on Day 1
|
Eksperimentel: Cohort 2
Healthy individuals with normal hepatic function.
|
2000 mg abiraterone acetate suspension on Day 1
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Mean plasma concentrations of abiraterone
Tidsramme: Up to Day 4
|
Up to Day 4
|
Mean plasma protein binding concentrations of abiraterone
Tidsramme: Screening Day -2
|
Screening Day -2
|
Maximum plasma concentrations of abiraterone
Tidsramme: Up to Day 4
|
Up to Day 4
|
Time to reach the maximum plasma concentration of abiraterone
Tidsramme: Up to Day 4
|
Up to Day 4
|
Area under the plasma concentration-time curve from time 0 to 24 hours after dosing of abiraterone
Tidsramme: Up to Day 4
|
Up to Day 4
|
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of abiraterone
Tidsramme: Up to Day 4
|
Up to Day 4
|
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
Tidsramme: Up to Day 4
|
Up to Day 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
|
Up to Day 4
|
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone
Tidsramme: Up to Day 4
|
Up to Day 4
|
Time to last quantifiable plasma concentration of abiraterone
Tidsramme: Up to Day 4
|
Up to Day 4
|
Total apparent clearance of drug after extravascular administration uncorrected for absolute bioavailability of abiraterone
Tidsramme: Up to Day 4
|
Up to Day 4
|
Apparent volume of distribution after extravascular administration uncorrected for absolute bioavailability of abiraterone
Tidsramme: Up to Day 4
|
Up to Day 4
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
The number of participants affected by an adverse event
Tidsramme: Up to Day 29
|
Up to Day 29
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Research, Janssen Research & Development, LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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. september 2012
Studieafslutning (Faktiske)
1. september 2012
Datoer for studieregistrering
Først indsendt
19. januar 2012
Først indsendt, der opfyldte QC-kriterier
19. januar 2012
Først opslået (Skøn)
24. januar 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. juni 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. juni 2014
Sidst verificeret
1. juni 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CR100779
- 212082PCR1004 (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 .
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