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A JNJ-56021927 (ARN-509; Apalutamide) QT/QTc Study

NCT02578797 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-11-09

No results posted yet for this study

Summary

The purpose of this study is to determine whether daily treatment with apalutamide affects the ventricular repolarization in participants with Castration-Resistant Prostate Cancer (CRPC)

Conditions

  • Castration-Resistant Prostate Cancer

Interventions

DRUG

Apalutamide

Study drug will be administered orally at a dose level of 240 mg daily (4 x 60 mg tablets) in treatment cycles of 28 days.

Sponsors & Collaborators

  • Aragon Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-18
Primary Completion
2016-09-20
Completion
2022-10-13

Countries

  • United States
  • Canada
  • Moldova
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02578797 on ClinicalTrials.gov