- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01516047
A Pharmacokinetic Study of Abiraterone Acetate in Patients With Severe Hepatic Impairment Compared to Patients With Normal Hepatic Function
24 juni 2014 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
16
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
Anaheim, California, Förenta staterna
-
-
Florida
-
Orlando, Florida, Förenta staterna
-
-
Texas
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San Antonio, Texas, Förenta staterna
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
35 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Manlig
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Cohort 1
Patients with severe hepatic impairment.
|
125 mg to 2000 mg abiraterone acetate suspension on Day 1
|
Experimentell: Cohort 2
Healthy individuals with normal hepatic function.
|
2000 mg abiraterone acetate suspension on Day 1
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Mean plasma concentrations of abiraterone
Tidsram: Up to Day 4
|
Up to Day 4
|
Mean plasma protein binding concentrations of abiraterone
Tidsram: Screening Day -2
|
Screening Day -2
|
Maximum plasma concentrations of abiraterone
Tidsram: Up to Day 4
|
Up to Day 4
|
Time to reach the maximum plasma concentration of abiraterone
Tidsram: 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
Tidsram: 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
Tidsram: Up to Day 4
|
Up to Day 4
|
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
Tidsram: 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
Tidsram: 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
Tidsram: Up to Day 4
|
Up to Day 4
|
Time to last quantifiable plasma concentration of abiraterone
Tidsram: Up to Day 4
|
Up to Day 4
|
Total apparent clearance of drug after extravascular administration uncorrected for absolute bioavailability of abiraterone
Tidsram: Up to Day 4
|
Up to Day 4
|
Apparent volume of distribution after extravascular administration uncorrected for absolute bioavailability of abiraterone
Tidsram: Up to Day 4
|
Up to Day 4
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
The number of participants affected by an adverse event
Tidsram: Up to Day 29
|
Up to Day 29
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Janssen Research & Development, LLC Clinical Research, Janssen Research & Development, LLC
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2012
Primärt slutförande (Faktisk)
1 september 2012
Avslutad studie (Faktisk)
1 september 2012
Studieregistreringsdatum
Först inskickad
19 januari 2012
Först inskickad som uppfyllde QC-kriterierna
19 januari 2012
Första postat (Uppskatta)
24 januari 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
25 juni 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 juni 2014
Senast verifierad
1 juni 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CR100779
- 212082PCR1004 (Annan identifierare: Janssen Research & Development, LLC)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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