14C-ARN-509 Microdose Absolute Bioavailability and Microtracer Absorption, Metabolism, and Excretion study in healthy volunteers

14C-ARN-509 Microdose Absolute Bioavailability and Microtracer Absorption, Metabolism, and Excretion study in healthy volunteers - 14C-ARN-509 microtracer label AME and absolute BA study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38777

Enrollment

Registered

2013-02-20

Start date

2013-03-07

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

Tumoren van de prostaat Cancer of the prostate Prostate Cancer

Interventions

Part A: One oral dose of 240 mg ARN-509 made up of 8 capsules and a 15 minute infusion of 14C-ARN-509 plus tracer amount of radioactivity (9.25 kBq) (15 min infusion starts 2 hours after oral dose)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male volunteers 50-80 years, inclusive BMI: 18.5 - 30.0 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 60 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 ARN-509 metabolite patterns in plasma, excretion of radioactivity, metabolite patterns in urine, feces and expired air, metabolite identity, absorption of ARN-509 Safety: adverse events, vital signs, ECG, clinical laboratory and physical examination.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)