HealthyPhase 1NCT01822041
14C-ARN-509 Microtracer Label AME and Absolute BA Study
A Phase 1 study testing ARN-509 in people with Healthy, run by Aragon Pharmaceuticals, Inc. at 1 site in Netherlands.
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). Read more about this study
- Who is it for?
- Ages 50 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ARN-509
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2013to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
PRA - Clinical Research Unit, University Medical Centre Groningen
Groningen
About this study
Official title: 14C-ARN-509 Microdose Absolute Bioavailability and Microtracer Absorption, Metabolism, and Excretion Study in Healthy Volunteers
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).
Read the 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.
- Conditions
- Healthy
- Being tested
- ARN-509
- Keywords
- healthy volunteers, mass balance study, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARN-509Drug
Single oral dose of 240 mg ARN-509
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: ARN-509 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass Balance
To determine the rate and routes of excretion of ARN-509 in urine, feces, and expired air
Measured: 2 months 10 days
Absolute Oral Bioavailability
To determine absolute oral bioavailability of ARN-509
Measured: 2 months 10 days
Secondary outcomes (1)
Metabolite Profile
To identify and quantify the ARN-509 metabolites in plasma, urine, and feces
Measured: 2 months 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aragon Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nada al Kotbi, MD, Principal investigator, PRA International Group BVHelen Pruim-Tait, MA, MSc, Study director, PRA International Group BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822041
- Sponsor's protocol ID
- ARN-509-006
- Other IDs
- 2012-004899-19
- Status last verified
- Sep 2013
- First submitted
- 26 Feb 2013
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 14C-ARN-509 Microdose Absolute Bioavailability and Microtracer Absorption, Metabolism, and Excretion Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01822041
- Acronym / sponsor ID
- ARN-509-006
- Conditions
- Healthy
- Keywords
- healthy volunteers, mass balance study, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aragon Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A - 14C labeled ARN-509 | Active comparator | Drug: ARN-509Single 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 |
| Part B: 14C labeled ARN-509 | Active comparator | Drug: ARN-509Single 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 |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARN-509Single oral dose of 240 mg ARN-509 | Drug | Part A - 14C labeled ARN-509, Part B: 14C labeled ARN-509 |
Primary outcome
Mass Balance
Time frame: 2 months 10 days
To determine the rate and routes of excretion of ARN-509 in urine, feces, and expired air
Absolute Oral Bioavailability
Time frame: 2 months 10 days
To determine absolute oral bioavailability of ARN-509
1 secondary outcome
Metabolite Profile
Time frame: 2 months 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nada al Kotbi, MD principal investigator
PRA International Group BV
Helen Pruim-Tait, MA, MSc study director
PRA International Group BV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARN-509 in people with Healthy, run by Aragon Pharmaceuticals, Inc. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mass Balance (time frame: 2 months 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2013.