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

NCT01822041 | Completed Phase 1

• 2 other identifiers: ARN-509-0062012-004899-19
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

healthy volunteers; mass balance study; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Metabolite Profile

  2 months 10 days

Study Arms (2)

Part A - 14C labeled ARN-509

ACTIVE COMPARATOR

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

Part B: 14C labeled ARN-509

ACTIVE COMPARATOR

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

Interventions

ARN-509 DRUG

Single oral dose of 240 mg ARN-509

Part A - 14C labeled ARN-509; Part B: 14C labeled ARN-509

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aragon Pharmaceuticals, Inc.: lead

Study Sites (1)

PRA - Clinical Research Unit, University Medical Centre Groningen

Groningen, Netherlands

Location

MeSH Terms

Interventions

apalutamide

Study Officials

• Nada al Kotbi, MD

  PRA International Group BV

  PRINCIPAL INVESTIGATOR

• Helen Pruim-Tait, MA, MSc

  PRA International Group BV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: April 2, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 13, 2013

Record last verified: 2013-09

Locations

NL (1)