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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822041
• Other study ID #: ARN-509-006
• Secondary ID: 2012-004899-19
• Status: Completed
• Phase: Phase 1
• First received: February 26, 2013
• Last updated: September 12, 2013
• Start date: March 2013
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: Aragon Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ARN-509
Single oral dose of 240 mg ARN-509

Locations

Country	Name	City	State
Netherlands	PRA - Clinical Research Unit, University Medical Centre Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Aragon Pharmaceuticals, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mass Balance	To determine the rate and routes of excretion of ARN-509 in urine, feces, and expired air	2 months 10 days	No
Primary	Absolute Oral Bioavailability	To determine absolute oral bioavailability of ARN-509	2 months 10 days	No
Secondary	Metabolite Profile	To identify and quantify the ARN-509 metabolites in plasma, urine, and feces	2 months 10 days	No