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 januari 2014 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
51
Fas
- Fas 1
Kontakter och platser
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Studieorter
-
-
California
-
Cypress, California, 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
25 år till 35 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
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
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: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Behandling B
|
Standardized meal administered 1 hour after the 1000 mg abiraterone acetate dose
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|
Experimentell: Behandling C
|
Standardized meal administered 2 hours before the 1000 mg abiraterone acetate dose
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Experimentell: Behandling A
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1000 mg abiraterone acetate administered in the fasting state
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Experimentell: Behandling D
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Standardized meal administered 2 hours before and 2 hours after the 1000 mg abiraterone acetate dose
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Changes in mean plasma concentrations of abiraterone
Tidsram: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Mean plasma concentrations of abiraterone
Tidsram: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
|
Maximum plasma concentration of abiraterone
Tidsram: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
|
Time to reach the maximum plasma concentration of abiraterone
Tidsram: 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
Tidsram: Up to Day 4, treatment period 4
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Up to Day 4, treatment period 4
|
|
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
Tidsram: 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
Tidsram: 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
Tidsram: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
|
Time to last quantifiable plasma concentration of abiraterone
Tidsram: 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
Tidsram: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
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The number of participants affected by an adverse event
Tidsram: 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
|
Samarbetspartners och utredare
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Publikationer och användbara länkar
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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 maj 2012
Avslutad studie (Faktisk)
1 maj 2012
Studieregistreringsdatum
Först inskickad
19 januari 2012
Först inskickad som uppfyllde QC-kriterierna
10 april 2012
Första postat (Uppskatta)
11 april 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
10 januari 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 januari 2014
Senast verifierad
1 januari 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- CR100737
- 212082PCR1005 (Annan identifierare: Janssen Research & Development, LLC)
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