A Study to Evaluate the Effect of Multiple Doses of JNJ-56021927 on the Pharmacokinetics of Multiple Cytochrome P450 and Transporter Substrates in Participants With Castration-Resistant Prostate Cancer

Launched by ARAGON PHARMACEUTICALS, INC. · Oct 29, 2015

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called JNJ-56021927 to see how it affects the way the body processes certain medications in men with castration-resistant prostate cancer, a type of prostate cancer that does not respond to hormone therapy. The researchers want to understand how repeated doses of this treatment interact with various enzymes and transporters in the body, which are important for breaking down and moving drugs.

To be eligible for this study, participants must be men aged 65 to 74 with a specific type of prostate cancer and must have testosterone levels below a certain point. They should also be in relatively good health, without serious conditions like brain metastases or recent chemotherapy. Participants can expect to receive the study drug and undergo tests to monitor how their body handles other medications. It's important for potential participants to know that they need to avoid certain medications before and during the trial, and that they will be closely monitored throughout the study.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
• • Adenocarcinoma of the prostate
• • Participants with non-metastatic castration-resistant prostate cancer (NM-CRPC) or metastatic castration-resistant prostate cancer (mCRPC), who in the opinion of the investigator may benefit from treatment with JNJ-56021927
• • Surgically or medically castrated, with testosterone levels of \<50 nanogram per deciliter (ng/dL)
• • If the participant is being treated with a gonadotropin-releasing hormone (GnRHa) (ie, participant who has not undergone bilateral orchiectomy), then this therapy must have been initiated at least 4 weeks prior to the Cycle 1 Day 1 visit and must be continued throughout the study
• • Adequate bone marrow and organ function defined as: Hemoglobin (\>=9.0 g/dL, independent of transfusion or growth factor support within the prior 7 days); Absolute neutrophil count (\>=1000/mm\^3 independent of growth factor support within the prior 7 days); Platelet count (\>=75,000/mm\^3 independent of transfusion or growth factor support within the prior 7 days); Serum albumin (\>=3.0 g/dL); Serum creatinine (\<=1.5\*upper limit of normal (ULN) or calculated creatinine clearance \>=50 mL/min/1.73m\^2); Total bilirubin \[\<1.5\*ULN (participants with Gilbert's Syndrome may be enrolled if the total bilirubin is \<4 mg/dL with predominance of indirect bilirubin \>=80% of total bilirubin\]); Aspartate aminotransferase or alanine aminotransferase (\<=3.0\*ULN); Prothrombin time (PT) or partial thromboplastin time (PTT) or international normalized ratio (INR) (PT \<=15 sec or INR \<=1.2 PTT \<=40 sec).
• Exclusion Criteria:
• • Known brain metastases
• • Chemotherapy or immunotherapy for the treatment of prostate cancer within 4 weeks of the Study Day 15 (Cycle 1 Day 1) visit
• • Prior treatment with enzalutamide within 8 weeks before first dose of drug probes
• • Therapies that must be discontinued or substituted prior to study visit Day 1, or must be temporarily interrupted during the course of the study, include the following: a) Medications known to lower the seizure threshold within 4 weeks before Study Day 15 (Cycle 1 Day 1) and b) Medications known to induce or inhibit drug metabolizing enzymes (CYP3A4, CYP2C9, CYP2C19 and CYP2C8) or transporter proteins (P-gp, BRCP, OATP1B1, and OATPB3)
• • Participant has known allergies, hypersensitivity, or intolerance to any of the study drugs/drug probes or excipients
• • History of seizure or any condition that may predispose to seizure within 12 months prior to enrollment (Study Day 1); brain arteriovenous malformation; or intercranial masses such as schwannoma or meningioma that is causing edema or mass effect
• • Participants with poor metabolizer genotype for CYP2C9 (\*2, \*3), or CYP2C19 (\*2, \*3, \*4, \*8)