Status:
COMPLETED
14C-ARN-509 Microtracer Label AME and Absolute BA Study
Lead Sponsor:
Aragon Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
MALE
50-80 years
Phase:
PHASE1
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 st...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01822041
Start Date
March 1 2013
End Date
June 1 2013
Last Update
September 13 2013
Active Locations (1)
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1
PRA - Clinical Research Unit, University Medical Centre Groningen
Groningen, Netherlands