An open-label, single center study to determine the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]LDE225 (74 kBq) to healthy male subjects

Completed

• Conditions: kwaadaardige tumoren; malignant tumors

• Registration Number: NL-OMON37376
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

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

Inclusion Criteria

Healthy male volunteers
18-55 years, inclusive
BMI: 18.0 * 32.9 kg/m2, inclusive
non-smoking

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>Pharmacokinetics: blood and plasma concentrations of radioactivity, plasma<br /><br>concentrations of LDE255 and LGE899,<br /><br>metabolite patterns in plasma, excretion of radioactivity, metabolite patterns<br /><br>in urine and feces, metabolite identity,<br /><br>absorption of LDE255<br /><br>Pharmacogenetics<br /><br>Safety: adverse events, vital signs, ECG, clinical laboratory and physical<br /><br>examination.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n/a</p><br>