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

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 - LDE225 ADME study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37376

Enrollment

Registered

2012-06-13

Start date

2012-06-28

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

kwaadaardige tumoren malignant tumors

Interventions

One oral dose of 800 mg LDE225 plus tracer amount of radioactivity (74 kBq) made up of 16 50 mg capsules.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male volunteers 18-55 years, inclusive BMI: 18.0 * 32.9 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 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: blood and plasma concentrations of radioactivity, plasma concentrations of LDE255 and LGE899, metabolite patterns in plasma, excretion of radioactivity, metabolite patterns in urine and feces, metabolite identity, absorption of LDE255 Pharmacogenetics Safety: adverse events, vital signs, ECG, clinical laboratory and physical examination.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)