check_circleStudy Completed

Neoplasms

Roniciclib Mass Balance Study

Trial purpose

The purpose of this trial is to investigate the fate of the roniciclib (study drug) in the body in a so called mass-balance study. This means to investigate how the study drug is absorbed, distributed, broken down (metabolized) and removed (excreted or eliminated) from the body.

Key Participants Requirements

Sex

Both

Age

18 - 99 Years

Trial summary

Enrollment Goal
7
Trial Dates
April 2015 - June 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Roniciclib (BAY1000394)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
PRA Magyarorszag Kft. Fazis I-es Klin.Farmakol. VizsgalohelyBudapest, 1077, Hungary

Primary Outcome

  • Amount of Roniciclib in urine as percentage of the dose of total radioactivity.
    date_rangeTime Frame:
    Up to 336 hours
    enhanced_encryption
    Safety Issue:
    No
  • Amount of Roniciclib in feces as percentage of the dose of total radioactivity.
    date_rangeTime Frame:
    Up to 336 hours
    enhanced_encryption
    Safety Issue:
    No
  • Amount of Roniciclib in vomit as percentage of the dose of total radioactivity
    date_rangeTime Frame:
    Up to 336 hours
    enhanced_encryption
    Safety Issue:
    No
  • Cmaxof roniciclib in plasma
    date_rangeTime Frame:
    up to 336 hours
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tlast) of roniciclib in plasma
    date_rangeTime Frame:
    up to 336 hours
    enhanced_encryption
    Safety Issue:
    No
  • AUC of roniciclib in plasma
    date_rangeTime Frame:
    up to 336 hours
    enhanced_encryption
    Safety Issue:
    No
  • Cmax of total radioactivity in whole blood and plasma
    date_rangeTime Frame:
    up to 336 hours
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tlast) of total radioactivity in whole blood and plasma
    date_rangeTime Frame:
    Up to 336 hours
    enhanced_encryption
    Safety Issue:
    No
  • AUC of total radioactivity in whole blood and plasma
    date_rangeTime Frame:
    up to 336 hours
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Phase I, single center, open-label, non-randomized, non-placebo-controlled study to investigate the metabolism, excretion pattern, mass balance, safety, tolerability and pharmacokinetics of orally administered [14C]-roniciclib (BAY 1000394) in patients with solid tumors
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
2