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

NCT ID: NCT01822041

Last Updated: 2013-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-06-30

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.

Conditions

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Healthy

Keywords

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healthy volunteers mass balance study Pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A - 14C labeled ARN-509

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

Group Type ACTIVE_COMPARATOR

ARN-509

Intervention Type DRUG

Single oral dose of 240 mg ARN-509

Part B: 14C labeled ARN-509

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

Group Type ACTIVE_COMPARATOR

ARN-509

Intervention Type DRUG

Single oral dose of 240 mg ARN-509

Interventions

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ARN-509

Single oral dose of 240 mg ARN-509

Intervention Type DRUG

Eligibility Criteria

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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

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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aragon Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nada al Kotbi, MD

Role: PRINCIPAL_INVESTIGATOR

PRA International Group BV

Helen Pruim-Tait, MA, MSc

Role: STUDY_DIRECTOR

PRA International Group BV

Locations

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PRA - Clinical Research Unit, University Medical Centre Groningen

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2012-004899-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ARN-509-006

Identifier Type: -

Identifier Source: org_study_id