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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01822041

Enrollment

Registered

2013-04-02

Start date

2013-03-31

Completion date

2013-06-30

Last updated

2013-09-13

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

Conditions

Healthy

Keywords

healthy volunteers, mass balance study, Pharmacokinetics

Brief summary

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

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.

Interventions

DRUGARN-509

Single oral dose of 240 mg ARN-509

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: 1. Gender : male 2. Age : 50 - 80 years, inclusive 3. Body Mass Index (BMI) : 18.5-30.0 kg/m2 4. 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 5. Medical history without major pathology Key

Exclusion criteria

1. Evidence of clinically relevant pathology. 2. Mental handicap. 3. History of relevant drug and/or food allergies. 4. Regular/routine treatment with non-topical medications within 30 days prior to entry into the clinical research center. 5. Smoking. 6. History of alcohol abuse or drug addiction (including soft drugs like cannabis products). 7. Use of concomitant medication, except for acetaminophen (paracetamol) and topical medications 8. Irregular defecation pattern (less than once per 2 days). 9. Positive drug screen (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, and alcohol). 10. 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). 11. Positive screen on HBsAg, anti-HCV or anti-HIV 1/2. 12. Illness within five days prior to drug administration.

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026