Prostate Cancer Clinical Trial
Official title:
A Phase 1 Open-label Study to Evaluate the Effect of Multiple Doses of Enzalutamide on the Pharmacokinetics of Substrates for CYP1A2 and CYP2D6 in Male Subjects With Prostate Cancer
Verified date | June 2017 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates how once daily enzalutamide affects the metabolism of caffeine and dextromethorphan in men with prostate cancer by measuring concentrations of these drugs and their metabolites in plasma.
Status | Completed |
Enrollment | 12 |
Est. completion date | February 3, 2014 |
Est. primary completion date | February 3, 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subject is a male aged 18 years old or older (at screening) with histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant setting). Subjects may be on ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or have undergone prior bilateral orchiectomy at screening. - Subject has progressive disease by prostate-specific antigen (PSA) or imaging. - Subject has received no more than 2 prior chemotherapy regimens. - Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. - Male subject must use a condom if having sex with a pregnant woman. - Male subject and their female spouse/partners who are of childbearing potential must use 2 acceptable methods of birth control starting at screening and continuing throughout the study period and for 3 months after final study drug administration. - Subject has an estimated life expectancy of at least 6 months. Exclusion Criteria: - Subject has confirmed CYP2D6 poor metabolizer, or CYP2D6 ultrarapid metabolizer status based on genotyping analysis. - Subject has known metastases in the liver or any hepatic disorder that could affect drug metabolism deemed clinically significant by the investigator after discussion with the sponsor. - Subject has undergone major surgery within 4 weeks prior to day 1. - Subject received treatment with chemotherapy within 4 weeks prior to enrollment (day 1 visit) or plans to initiate treatment with chemotherapy during the study. - Subject uses concomitant medications that are potent inducers and/or inhibitors of CYP1A2, CYP2C8, CYP2D6, or CYP3A4. |
Country | Name | City | State |
---|---|---|---|
Moldova, Republic of | Arensia | Chisinau |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Europe B.V. | Medivation, Inc. |
Moldova, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PK measured by Pharmacokinetic parameter Maximum concentration (Cmax) | For the probe substrates (caffeine and dextromethorphan) in combination with enzalutamide PTM and in combination with enzalutamide. | Day 1 and Day 53 (28 times) | |
Primary | PK measured by Pharmacokinetic parameter Area under the curve (AUC) from the time of dosing to the last measurable concentration (AUC0-t) | For the probe substrates (caffeine and dextromethorphan) in combination with enzalutamide PTM and in combination with enzalutamide. | Day 1 and Day 53 (28 times) | |
Primary | PK measured by PK parameter area under the curve (AUC) from time 0 extrapolated to infinity (AUC0-inf) | For the probe substrates (caffeine and dextromethorphan) in combination with enzalutamide PTM and in combination with enzalutamide. | Day 1 and Day 53 (28 times) | |
Secondary | PK measured by PK parameters tmax, terminal elimination half-life (t1/2), apparent total systemic clearance after oral dosing (CL/F), apparent volume of distribution during terminal elimination phase (Vz/F) and extrapolated AUC (%AUC) | Tmax is time to maximum concentration. These PK parameters will be measured for the probe substrates (caffeine and dextromethorphan) in combination with enzalutamide PTM and in combination with enzalutamide. | Day 1 and Day 53 (28 times) | |
Secondary | PK measured by PK parameters Cmax, AUC0-t, AUC0-inf, %AUC, tmax and t1/2 | For 1,7-dimethylxanthine (metabolite caffeine), dextrorphan (metabolite dextromethorphan). | Day 1 and Day 53 (28 times) | |
Secondary | PK measured by PK parameters Cmax, trough concentrations (Ctrough) at Days 28, 52, 53, 54 and 55, tmax, AUC during the time interval between consecutive dosing (AUCtau), CL/F (parent only) and peak-to-trough ratio (PTR) | For Enzalutamide, N-desmethyl enzalutamide (M2) and sum of enzalutamide + M2. | Day 28 (± 1 day), and Days 52 to 55 (15 times) | |
Secondary | Safety and tolerability measured by vital signs, adverse events, laboratory assessments and electrocardiogram | Screening (Day -28 to Day -7) to ESV (>153 times) |
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