A single-center, open-label study to investigate the absorption, distribution, metabolism and excretion (ADME) of INC280 after a single oral dose of 600 mg [14C] INC280 (5.55 MBq) in healthy male subjects

A single-center, open-label study to investigate the absorption, distribution, metabolism and excretion (ADME) of INC280 after a single oral dose of 600 mg [14C] INC280 (5.55 MBq) in healthy male subjects - Human metabolism and mass balance study of INC280

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41012

Enrollment

Registered

2014-10-07

Start date

2014-11-12

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

verschillende vormen van kanker cancer

Interventions

During the study teh volunteers will receive the study medication after an overnight fast (at least 10 hours) as 12 capsules of 50 mg each, together with a minimum of 240 milliliters and a maximum o

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 45-65 years, inclusive BMI: 18 - 29 kg/m2, inclusive

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 0.4 liters of blood in the 8 weeksprior the start of this study.

Design outcomes

Primary

Measure	Time frame
* To determine the rates and routes of excretion of [14C]INC280 related radioactivity, including mass balance of total drug-related radioactivity in urine and feces, following the administration of a single 600 mg oral dose of [14C]INC280 to healthy male subjects. * To determine the pharmacokinetics of total radioactivity in blood and plasma. * To characterize the plasma pharmacokinetics of INC280	—

Measure

Time frame

* To determine the rates and routes of excretion of [14C]INC280 related radioactivity, including mass balance of total drug-related radioactivity in urine and feces, following the administration of a single 600 mg oral dose of [14C]INC280 to healthy male subjects. * To determine the pharmacokinetics of total radioactivity in blood and plasma. * To characterize the plasma pharmacokinetics of INC280

—

Secondary

Measure	Time frame
* To assess the safety and tolerability of a single 600 mg oral dose of [14C]INC280 administered to healthy male subjects.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)