check_circleStudy Completed

Clinical Trial, Phase I, Pharmacokinetics

Rogaratinib (BAY1163877) human mass balance study

Trial purpose

The objective of this study is to determine the mass balance and routes of excretion of total radioactivity after a single oral 200 mg dose of [14C]rogaratinib given as a solution. For further clinical development, human mass balance data are required to elucidate the absorption, distribution, metabolism, and excretion (ADME) of rogaratinib.

Key Participants Requirements

Sex

Male

Age

21 - 65 Years

Trial summary

Enrollment Goal
6
Trial Dates
April 2018 - August 2018
Phase
Phase 1
Could I Receive a placebo
No
Products
Rogaratinib (BAY1163877)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
PRAHealthSciencesGRONINGEN, 9728 NZ, Netherlands

Primary Outcome

  • Cmax of rogaratinib in plasma
    Cmax: maximum drug concentration in the measured matrix, directly taken from analytical data
    date_rangeTime Frame:
    At pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 h post-dose. Collection will be extended depending on the radioactivity recovery.
  • AUC(0-tlast) of rogaratinib in plasma
    AUC(0-tlast): area under the measured matrix concentration versus time curve to the last data point above the lower limit of quantitation
    date_rangeTime Frame:
    At pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 h post-dose. Collection will be extended depending on the radioactivity recovery.
  • AUC of rogaratinib in plasma
    AUC: area under the measured matrix concentration versus time curve from the first time point (t=0) extrapolated to infinity
    date_rangeTime Frame:
    At pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 h post-dose. Collection will be extended depending on the radioactivity recovery.
  • Cmax of total radioactivity in plasma and whole blood
    date_rangeTime Frame:
    At pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 h post-dose. Collection will be extended depending on the radioactivity recovery.
  • AUC(0-tlast) of total radioactivity in plasma and whole blood
    date_rangeTime Frame:
    At pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 h post-dose. Collection will be extended depending on the radioactivity recovery.
  • AUC of total radioactivity in plasma and whole blood
    date_rangeTime Frame:
    At pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 h post-dose. Collection will be extended depending on the radioactivity recovery.
  • AE,ur (%) of rogaratinib and its metabolites
    AE,ur: amount excreted into urine from 0 to infinity
    date_rangeTime Frame:
    In intervals of 12h from Day -1 till Day 2 and in intervals of 24h afterwards: at pre-dose (-12–0h), 0–12, 12–24, 24–48, 48–72, 72–96,96–120, 120–144 and 144–168 hours post dose. Collection will be extended depending on the radioactivity recovery.
  • AE,fec (%) of rogaratinib and its metabolites
    AE,fec: amount excreted into feces from 0 to infinity
    date_rangeTime Frame:
    In intervals of 24h at pre dose (-18–0h), 0–24, 24–48, 48–72, 72–96, 96–120, 120–144 and 144–168 hours post dose. Collection will be extended depending on the radioactivity recovery.
  • AE,vom (%) of rogaratinib and its metabolites, if applicable
    AE,vom: amount excreted into vomit
    date_rangeTime Frame:
    During the first 6 hours after dosing

Trial design

Single center, open-label, non-randomized, non-placebo-controlled study to investigate the metabolism, excretion pattern, mass balance, safety, tolerability and pharmacokinetics after single administration of 200 mg [14C]rogaratinib (oral solution) in healthy male subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1