A Study to Determine the Effect of Food on the Pharmacokinetics of Abiraterone Acetate in Healthy Male Patients
A Phase 1, Single Dose, Open-Label, Three-Period, Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Abiraterone Acetate in Healthy Male Subjects
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Studientyp
Einschreibung (Tatsächlich)
Einschreibung
Phase
Phase
- Phase 1
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- In good general health as determined by no clinically significant findings on medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory measurements
- Body mass index within 18 kg/m2 to 32 kg/m2, inclusive
- Non-tobacco users
- Clinical laboratory values within protocol-defined parameters
- Negative hepatitis panel (including hepatitis B surface antigen [HBsAg] and hepatitis C virus antibody [anti-HCV]),and negative human immunodeficiency virus (HIV) antibody screens
- Negative test for selected drugs of abuse
- Agrees to protocol-defined use of effective contraception
Exclusion Criteria:
- Significant history or manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological or psychiatric disorder, as determined by the Principal Investigator
- History or presence of an abnormal electrocardiogram
- History of stomach or intestinal surgery resection that would potentially alter absorption and/or excretion of orally administered drugs
- Screening serum total testosterone of <200 ng/dL
- History of hypersensitivity reaction to the study drug, related compounds or excipients used in the formulation
- Receipt of an investigational drug within 5 half-lives or 30 days prior to Day -1, whichever is longer
- Abnormal diet during the 30 days prior to Day 1
- Donation of blood or significant loss of blood within 56 days or plasma within 14 days prior to Day -1
- Planned donation of blood or plasma from Screening through Study Completion, Day 21
- Receipt of blood products within 2 months prior to Day 1
- History of protocol-defined alcohol abuse
- Known or suspected use of illicit drugs within the last year
- Use of any medication on a chronic basis
- Use of any prescription medications/products or over-the-counter non-prescription preparations within 5 half-lives or 7 days prior to Day -1 unless deemed acceptable by the Sponsor
- Consumption of alcohol-containing foods or beverages within 24 hours prior to the first Check-in (Day -1)
- Unwillingness to abstain from alcohol consumption from Day -1 to Study Completion (Day21)
- Consumption of caffeine-containing or grapefruit-containing foods or beverages within 72 hours prior to Day -1
- Unwillingness to abstain from caffeine-containing or grapefruit-containing foods or beverages from Day -1 through Study Completion (Day21)
- Presence of sexual dysfunction or any medical condition that would affect sexual function
- Unwillingness to refrain from strenuous exercise from 48 hours prior to Day -1 and for the duration of the study
- Presence of any condition that, in the opinion of the Investigator, would limit the participant's ability to complete and/or participate in this study
- Unwillingness to refrain from using any tobacco or nicotine-containing products during screening and throughout the study to Study Completion (Day 21)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
|
Experimental: Sequenz ABC
|
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state
|
|
Experimental: Sequenz ACB
|
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state
|
|
Experimental: Sequenz BAC
|
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state
|
|
Experimental: Sequenz BCA
|
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state
|
|
Experimental: Sequenz-CAB
|
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state
|
|
Experimental: Sequenz CBA
|
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state
|
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Maximum observed concentration of abiraterone
Zeitfenster: Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
|
Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
|
|
Time to maximum concentration of abiraterone
Zeitfenster: Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
|
Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
|
|
Area under the concentration-time curve from time 0 to the last measurable concentration of abiraterone
Zeitfenster: Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
|
Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
|
|
Area under the concentration-time curve extrapolated to infinity of abiraterone
Zeitfenster: Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
|
Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
|
|
Apparent plasma terminal elimination rate constant of abiraterone
Zeitfenster: Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
|
Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
|
|
Apparent terminal elimination half-life of abiraterone
Zeitfenster: Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
|
Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
|
Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Number of participants affected by an adverse event
Zeitfenster: Up to Day 21
|
Up to Day 21
|
Mitarbeiter und Ermittler
Sponsor
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienbeginn
Primärer Abschluss (Tatsächlich)
Primärer Abschluss
Studienabschluss (Tatsächlich)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- CR016960
- COU-AA-009 (Andere Kennung: Cougar Biotechnology, Inc.)
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