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

Completed

• Conditions: 10027655; tumoren; Tumors

• Registration Number: NL-OMON46572
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2018-12-14
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

-Healthy male subjects
-21 to 65 years, inclusive
-BMI 18.5 and 32.0 kg/m2 (inclusive)
-Total body weight of 55 to 100kg (inclusive)
-non-smoking or light smokers (not more than 5 cigarettes daily)
-Use adequate contraception during the study and in the 3 months following dosing

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-To determine the mass balance and routes of excretion of total radioactivity<br /><br>after a single oral 200mg dose of [14C]rogaratinib given as a solution<br /><br>-To quantify rogaratinib concentrations in plasma *<br /><br>-To quantify total radioactivity in whole blood and plasma </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are not applicable in this study.<br /><br><br /><br>Other objectives of this study are: *<br /><br>-To provide plasma and excreta samples for further metabolite profiling and<br /><br>chemical structure identification (to be reported separately) *<br /><br>-To provide additional information on the safety and tolerability of a single<br /><br>oral dose of 200mg rogaratinib </p><br>