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

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 - Rogaratinib (BAY1163877) human mass balance study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46572

Enrollment

Registered

2018-03-13

Start date

2018-04-06

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tumoren Tumors

Interventions

The volunteer will receive a single dose of 200 mg/3.7 MBq radiolabeled rogaratinib as an oral solution. Thereafter you are also required to drink an additional amount of 100 mL of non-sparkling wa

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
-To determine the mass balance and routes of excretion of total radioactivity after a single oral 200mg dose of [14C]rogaratinib given as a solution -To quantify rogaratinib concentrations in plasma * -To quantify total radioactivity in whole blood and plasma	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)