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

Part of paid clinical trials in Greenville, South Carolina.

Sponsor
Aragon Pharmaceuticals, Inc.
Study ID
NCT02578797
Phase
PHASE1
Status
Completed

Conditions

  • Castration-Resistant Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apalutamide — DRUG
    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.

Study Details

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)

Key Dates

Start date
Dec 18, 2015
Status verified
Nov 2023
Primary completion
Sep 20, 2016
Completion
Oct 13, 2022

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apalutamide
    Prostate Cancer participants will receive the study drug on an outpatient basis except for Cycle 1 (Day 1 and Day 2) and Cycle 3 (Day 1), when intake must occur at study site under overnight fasted conditions.

Primary Outcome Measure

QTc Fridericia (QTcF) parameter [ Time Frame: Day-1 and Day 1 (Cycle 1) and Day 1 (Cycle 3) ]

Locations (1)

FacilityCityStateZIPSite coordinators
-GreenvilleSouth Carolina--

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