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
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Todellinen)
Ilmoittautuminen
Vaihe
Vaihe
- Vaihe 1
Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
|
Kokeellinen: Jakso 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
|
|
Kokeellinen: ACB -sekvenssi
|
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
|
|
Kokeellinen: Sekvenssi 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
|
|
Kokeellinen: Sekvenssi 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
|
|
Kokeellinen: Järjestys 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
|
|
Kokeellinen: Sekvenssi 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
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
Maximum observed concentration of abiraterone
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
Number of participants affected by an adverse event
Aikaikkuna: Up to Day 21
|
Up to Day 21
|
Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Ensisijainen valmistuminen
Opintojen valmistuminen (Todellinen)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- CR016960
- COU-AA-009 (Muu tunniste: Cougar Biotechnology, Inc.)
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