A JNJ-56021927 (ARN-509; Apalutamide) QT/QTc Study
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|ClinicalTrials.gov Identifier: NCT02578797|
Recruitment Status : Active, not recruiting
First Posted : October 19, 2015
Last Update Posted : May 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Castration-Resistant Prostate Cancer||Drug: Apalutamide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Phase 1b QT/QTc Study of JNJ-56021927 (ARN-509) in Subjects With Castration-Resistant Prostate Cancer|
|Actual Study Start Date :||December 18, 2015|
|Actual Primary Completion Date :||September 20, 2016|
|Estimated Study Completion Date :||October 15, 2020|
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.
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.
- QTc Fridericia (QTcF) parameter [ Time Frame: Day-1 and Day 1 (Cycle 1) and Day 1 (Cycle 3) ]Mean change from baseline in QTcF as measured based on triplicate electrocardiograms extracted from continuous 12-lead Holter monitor recordings after study drug intake.
- Electrocardiographic parameters (HR, RR, PR, and QRS) [ Time Frame: Day-1 and Day 1 (Cycle 1) and Day 1 (Cycle 3) ]A change from time-matched baseline measurements in HR, PR, RR and QRS interval will be determined on Day -1, Day 1 and Day 3
- Electrocardiographic parameters (QT) [ Time Frame: Day-1 and Day 1 (Cycle 1) and Day 1 (Cycle 3) ]QT interval on a surface ECG will be corrected for heart rate using Bazett formula (QTcB) and study-specific Power (QTcP) if appropriate at each treatment period.
- Electrocardiographic parameters T- and U-wave morphology [ Time Frame: Day-1 and Day 1 (Cycle 1) and Day 1 (Cycle 3) ]Number and percentage of participants with changes from baseline
- Plasma concentrations apalutamide (and its active metabolite JNJ-56142060) [ Time Frame: Day-1, Day 1 and Day 2 (Cycle 1) and Day 1 (Cycle 3) ]Blood samples will be taken following dose administration.
- Number of participants with Adverse Events [ Time Frame: Day-1, Day 1 and Day 15 (Cycle 1); Day 1 and Day 15 (Cycle 2) and Day 1 (Cycle 3). ]Participants will be monitored for safety during the Screening and Treatment Phases, and up to 30 days after the last dose of study drug. From Cycle 4 onward collection of Adverse Events (AEs) will be limited to Grade 3 or higher and all Serious AEs from the remainder of the study.
- Pharmacokinetic parameter area under the plasma drug concentration-time curve (AUC) from time 0 to 24 hours [ Time Frame: Day 1 and Day 2 (Cycle 1) and Day 1 (Cycle 3) ]The AUC(0-24h) is the area under the plasma concentration-time curve from time 0 to time 24 hours after dosing.
- Pharmacokinetic parameter maximum concentration observed (Cmax) [ Time Frame: Day 1 and Day 2 (Cycle 1) and Day 1 (Cycle 3) ]The Cmax is the maximum observed plasma concentration.
- Pharmacokinetic parameter time to reach Cmax (tmax) [ Time Frame: Day 1 and Day 2 (Cycle 1) and Day 1 (Cycle 3) ]The tmax is the time to reach the maximum observed plasma concentration.
- Pharmacokinetic parameter minimum observed plasma concentration (Cmin) [ Time Frame: Cmin will only be collected on Day 1, Cycle 3 ]The Cmin is the minimum observed plasma concentration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578797
|United States, South Carolina|
|Greenville, South Carolina, United States|
|Montreal, Quebec, Canada|
|Moldova, Republic of|
|Chisinau, Moldova, Republic of|
|Sutton, United Kingdom|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|