check_circleStudy Completed

Prostatic Neoplasms

Phase 1 dose escalation study of BAY 1841788 in Japanese metastatic castration-resistant prostate cancer (mCRPC) subjects

Trial purpose

The primary objectives of this study are to investigate the safety and tolerability of BAY 1841788 in Japanese subjects with metastatic castration-resistant prostate cancer (mCRPC) and the PK of BAY 1841788 and its major metabolite BAY 1896953.

Key Participants Requirements

Sex

Male

Age

20 - N/A

Trial summary

Enrollment Goal
9
Trial Dates
February 2015 - January 2018
Phase
Phase 1
Could I Receive a placebo
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kashiwa, 277-8577, Japan

Primary Outcome

  • Number of participants with Treatment Emergent Adverse Event as measure of safety and tolerability
    date_rangeTime Frame:
    Up to 12 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • The intensity of an adverse event graded using the NCI CTCAE version 4.03
    National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE)
    date_rangeTime Frame:
    Up to 12 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Plasma concentration of BAY 1841788 characterized by Cmax
    Cmax: maximum drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of BAY 1841788 characterized by tmax
    tmax: time to reach maximum drug concentration in plasma after single (first) dose
    date_rangeTime Frame:
    Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of BAY 1841788 characterized by AUC(0-12)
    AUC(0-12):AUC from time 0 to 12 hours after administration
    date_rangeTime Frame:
    Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of metabolite BAY 1896953 characterized by Cmax
    Cmax: maximum drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of metabolite BAY 1896953 characterized by tmax
    tmax: time to reach maximum drug concentration in plasma after single (first) dose
    date_rangeTime Frame:
    Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of metabolite BAY 1896953 characterized by AUC(0-12)
    AUC(0-12):AUC from time 0 to 12 hours after administration
    date_rangeTime Frame:
    Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of diastereomers BAY 1896951 characterized by Cmax
    Cmax: maximum drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of diastereomers BAY 1896951 characterized by tmax
    tmax: time to reach maximum drug concentration in plasma after single (first) dose
    date_rangeTime Frame:
    Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of diastereomers BAY 1896951 characterized by AUC(0-12)
    AUC(0-12):AUC from time 0 to 12 hours after administration
    date_rangeTime Frame:
    Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of diastereomers BAY 1896952 characterized by Cmax
    Cmax: maximum drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of diastereomers BAY 1896952 characterized by tmax
    Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}
    date_rangeTime Frame:
    tmax: time to reach maximum drug concentration in plasma after single (first) dose
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of diastereomers BAY 1896952 characterized by AUC(0-12)
    AUC(0-12):AUC from time 0 to 12 hours after administration
    date_rangeTime Frame:
    Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}
    enhanced_encryption
    Safety Issue:
    No

Trial design

An open label Phase I study to evaluate the safety, tolerability and pharmacokinetics of BAY 1841788 in Japanese subjects with metastatic castration-resistant prostate cancer
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1