A single-center, open-label study to investigate the absorption, distribution, metabolism and excretion (ADME) of LEE011 after a single oral dose of 600 mg [14C]LEE011 (0.37 MBq) in healthy male subjects

A single-center, open-label study to investigate the absorption, distribution, metabolism and excretion (ADME) of LEE011 after a single oral dose of 600 mg [14C]LEE011 (0.37 MBq) in healthy male subjects - Human metabolism and mass balance study of LEE011

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40904

Enrollment

Registered

2014-09-18

Start date

2014-10-06

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

gevorderde kanker advance cancer

Interventions

The volunteer will receive a single dose of 600 mg radiolabeled study medication in the form of 3 capsules of 200 mg each

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 45 - 65 yrs, inclusive BMI: 18.0 - 30.0 kg/m2, inclusive non-smoking

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 weeks prior the start of this study.

Design outcomes

Primary

Measure	Time frame
* To determine the rates and routes of excretion of [14C]LEE011 related radioactivity, including mass balance of total drug-related radioactivity in urine and feces, following the oral administration of a single 600 mg dose of [14C]LEE011 to healthy male subjects. * To determine the pharmacokinetics of total radioactivity in blood and in plasma. * To characterize the plasma pharmacokinetics of LEE011 and known key metabolites, if applicable. * To characterize the urine concentrations of LEE011 and known key metabolites, if applicable.	—

Measure

Time frame

* To determine the rates and routes of excretion of [14C]LEE011 related radioactivity, including mass balance of total drug-related radioactivity in urine and feces, following the oral administration of a single 600 mg dose of [14C]LEE011 to healthy male subjects. * To determine the pharmacokinetics of total radioactivity in blood and in plasma. * To characterize the plasma pharmacokinetics of LEE011 and known key metabolites, if applicable. * To characterize the urine concentrations of LEE011 and known key metabolites, if applicable.

—

Secondary

Measure	Time frame
* To assess the safety of a single 600 mg oral dose of [14C]LEE011 administered to healthy male subjects.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)