NCT02592317Active, not recruitingPhase 1
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
Drug-drug Interaction Study to Evaluate the Effect of Multiple Doses of JNJ-56021927 on the Pharmacokinetics of Multiple Cytochrome P450 and Transporter Substrates in Subjects With Castration-Resistant Prostate Cancer
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the effects of repeat dosing of JNJ-56021927 on the pharmacokinetics for single-dose multiple cytochrome P450 (CYP450) enzymes (CYP3A4, CYP2C9, CYP2C19, CYP2C8) and transporter (P-gp and BRCP) substrates in participants with castration-resistant prostate cancer (CRPC).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 29 Oct 2015
- Start date
- 12 Feb 2016
- Primary completion date
- 7 Nov 2016
- Lead sponsor
- Aragon Pharmaceuticals, Inc.
- Diseases
- Prostate cancer
- NCT number
- NCT02592317
- EudraCT number
- 2015-003691-72
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 23
- From 12 Feb 2016 to the primary completion date, 7 Nov 2016
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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
Other illness
- Chemotherapy or immunotherapy for the treatment of prostate cancer within 4 weeks of the Study Day 15 (Cycle 1 Day 1) visit
- Participant has known allergies, hypersensitivity, or intolerance to any of the study drugs/drug probes or excipients
Other
- Known brain metastases
- Participants with poor metabolizer genotype for CYP2C9 (\*2, \*3), or CYP2C19 (\*2, \*3, \*4, \*8)
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| - Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| - Coordinator of this site? Confirm its status | Chisinau | Moldova | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.