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Rogaratinib (BAY1163877) Human Mass Balance Study

NCT03484585 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-08-14

No results posted yet for this study

Summary

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.

Conditions

  • Clinical Trial, Phase I
  • Pharmacokinetics

Interventions

DRUG

Rogaratinib (BAY1163877)

Single dose, intake orally, 200 mg

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-06
Primary Completion
2018-05-25
Completion
2018-08-09

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03484585 on ClinicalTrials.gov