14C-ARN-509 Microtracer Label AME and Absolute BA Study

Study Overview
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Brief Summary
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This is study in healthy human volunteers to determine the absorption, metabolism, and excretion (AME) profile of ARN-509 as well as its absolute oral bioavailability (BA).

Detailed Description
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Two cohorts of 6 healthy volunteers will be enrolled for the AME and absolute BA parts, respectively. The dose for both cohorts is 240 mg. The expected exposure of the dose is 7-fold lower than the steady state reached in patients with castration-resistant prostate cancer.

Official Title
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14C-ARN-509 Microdose Absolute Bioavailability and Microtracer Absorption, Metabolism, and Excretion Study in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: ARN-509


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Gender : male Age : 50 - 80 years, inclusive Body Mass Index (BMI) : 18.5-30.0 kg/m2 Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, power drinks), grapefruit (juice) and tobacco products from 48 h prior to entry in the clinical research center until discharge Medical history without major pathology Key Exclusion Criteria: Evidence of clinically relevant pathology. Mental handicap. History of relevant drug and/or food allergies. Regular/routine treatment with non-topical medications within 30 days prior to entry into the clinical research center. Smoking. History of alcohol abuse or drug addiction (including soft drugs like cannabis products). Use of concomitant medication, except for acetaminophen (paracetamol) and topical medications Irregular defecation pattern (less than once per 2 days). Positive drug screen (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, and alcohol). Intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits). Positive screen on HBsAg, anti-HCV or anti-HIV 1/2. Illness within five days prior to drug administration.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Part A - 14C labeled ARN-509<br>Single oral dose of 240 mg ARN-509, followed after 2 hours (at the average tmax of ARN-509) by an intravenous (i.v.) microdose of 100 μg (9.25 kBq, 250 nCi) 14C-ARN-509 | Drug: ARN-509<br>* Single oral dose of 240 mg ARN-509<br>|
| Active Comparator: Part B: 14C labeled ARN-509<br>Single oral dose of 240 mg ARN-509, followed after 2 hours (at the average tmax of ARN-509) by an oral dose of 240 mg ARN-509 with 37 kBq (1000 nCi) of 14C-ARN-509 | Drug: ARN-509<br>* Single oral dose of 240 mg ARN-509<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass Balance | To determine the rate and routes of excretion of ARN-509 in urine, feces, and expired air | 2 months 10 days | 
| Absolute Oral Bioavailability | To determine absolute oral bioavailability of ARN-509 | 2 months 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolite Profile | To identify and quantify the ARN-509 metabolites in plasma, urine, and feces | 2 months 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy volunteers, mass balance study, Pharmacokinetics