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AzTrials

Healthy SubjectsPhase 1NCT01911715

A Study to Explore the Routes of Elimination of MDV3100

A Phase 1 study testing MDV3100 in people with Healthy Subjects and Pharmacokinetics of MDV3100, run by Astellas Pharma Europe B.V. at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A study to investigate the excretion routes of radio-labelled MDV3100. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Subjects, Pharmacokinetics of MDV3100
What is being tested?
MDV3100
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteNetherlands
Study dates
Apr 2011to Jul 2011
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 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Body Mass Index within 18.5 to 30.0kg/m2
  • Regular defecation pattern (minimum once per 2 days).
  • Subject must be non-fertile, i.e., surgically sterilized or must practice an adequate contraceptive method to prevent pregnancies as defined in the protocol.

Who cannot join

  • Known or suspected hypersensitivity to MDV3100, or any components of the formulation used.
  • Any of the liver function tests above the upper limit of normal. A retest to confirm the result may be performed once.
  • Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever).
  • Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows: Pulse <40 or >90 bpm; mean systolic blood pressure >140 mmHg ; mean diastolic blood pressure >90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically).
  • A QTc interval of > 430 ms after repeated measurements (consistently after duplicate measurements), a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS).
  • Use of any prescribed or OTC (over-the-counter) drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for occasional use of paracetamol (up to 3 g/day).
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  • Regular use of any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit.
  • Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.
  • Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a clinical study in the previous year.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • PRA International

    Zuidlaren, 9471GP

Other trials in Netherlands

About this study

Official title: A Phase I Open-label Study to Investigate the Mass Balance and Biotransformation of a Single Oral 160 mg (100 µCi) Dose of 14C-MDV3100 (ASP9785) in Healthy Male Subjects

A study to investigate the excretion routes of radio-labelled MDV3100.

Being tested
MDV3100
Keywords
Phase 1, Mass Balance, MDV3100, Xtandi, Enzalutamide, Metabolism, Excretion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MDV3100Drug

    Also called Xtandi, enzalutamide

    Oral

Study groups in NCT01911715
Study groupRoleWhat they receive
Single Oral MDV3100 doseExperimentalNot described
Receives: Drug: MDV3100

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by Maximum concentration (Cmax)

    Measured: Day 1 through Day 78 (21 times)

  2. Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by Time to attain Cmax (tmax)

    Time to attain Cmax (tmax)

    Measured: Day 1 through Day 78 (21 times)

  3. Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by Time to reach quantifiable concentrations (tlag)

    Measured: Day 1 through Day 78 (21 times)

  4. Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by AUC from the time of dosing to the last measurable concentration (AUC0-t)

    Measured: Day 1 through Day 78 (21 times)

  5. Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by AUC extrapolated to infinity (AUC0-inf)

    Measured: Day 1 through Day 78 (21 times)

  6. Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by Terminal Disposition Rate Constant (λz)

    Measured: Day 1 through Day 78 (21 times)

  7. Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by Apparent terminal elimination half life (t1/2)

    Measured: Day 1 through Day 78 (21 times)

  8. Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by Apparent total body clearance after extra vascular dosing (CL/F)

    Measured: Day 1 through Day 78 (21 times)

  9. Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by Apparent volume of distribution during the terminal phase after extra vascular dosing (Vz/F)

    Measured: Day 1 through Day 78 (21 times)

  10. Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by blood-to-plasma ratio (Ratio Cb/p)

    Measured: Day 1 through Day 78 (21 times)

  11. Assessment of 14C recovery in urine

    Measured: Day 1 through Day 78 (17 times)

  12. Assessment of 14C recovery in feces

    Measured: Day 1 through Day 78 (16 times)

  13. Assessment of total 14C recovery (urine and feces combined) within 24 hours

    Measured: Day 1 through Day 78 (17 times for urine and 16 times for feces)

  14. Assessment of total 14C recovery (urine and feces combined) after Time of last quantifiable concentration (tlast)

    Measured: Day 1 through Day 78 (17 times for urine and 16 times for feces)

  15. Assessment of Pharmacokinetic profile of MDV3100 and metabolites in plasma

    PK of MDV3100, MDPC0001, and MDPC0002 in plasma based on validated LC-MS/MS methods:

    • In plasma: Cmax, tmax, tlag, AUC0-t, AUC0-inf, λz, t1/2, CL/F (parent only), and Vz/F (parent only)

    The ratios of AUCMDV3100/AUC14C , AUCMDPC0001/AUCMDV3100 and AUCMDPC0001/AUC14C (and the same for MDPC0002) will be calculated

    Measured: Day 1 through Day 78 (21 times)

  16. Assessment of Pharmacokinetic profile of MDV3100 and metabolites in urine

    PK of MDV3100, MDPC0001, and MDPC0002 in urine based on validated LC-MS/MS methods:

    • In urine: Cumulative amount excreted in urine from time zero to the last measurable concentration after dosing (Ae0-t), Renal clearance (CLR), Percent of dose excreted in urine from time zero to the last measurable concentration after dosing (Ae0-t%), Cumulative amount excreted in urine from time zero extrapolated to infinity (Ae0-inf), Percent of dose excreted in urine from time zero extrapolated to infinity (Ae0-inf%)

    The ratios of AUCMDV3100/AUC14C , AUCMDPC0001/AUCMDV3100 and AUCMDPC0001/AUC14C (and the same for MDPC0002) will be calculated

    Measured: Day 1 through Day 78 (17 times)

  17. Metabolic Profile: Profiling of possible metabolites of MDV3100 in plasma, urine, and feces

    Identification and possible quantification of metabolites in plasma, and if applicable, in urine and feces

    Measured: Day 1 through Day 78 (14 times)

Secondary outcomes (1)

  1. Safety as assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs)

    Measured: Day 1 through Day 78

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2013 (estimated)
  2. Study startApr 2011
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01911715
Sponsor's protocol ID
9785-CL-0001
Other IDs
2011-000089-37
Status last verified
Jul 2013
First submitted
26 Jul 2013
Last updated
30 Jul 2013
Results posted
No
Data monitoring committee
No

Publications

  • Gibbons JA, Ouatas T, Krauwinkel W, Ohtsu Y, van der Walt JS, Beddo V, de Vries M, Mordenti J. Clinical Pharmacokinetic Studies of Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1043-55. doi: 10.1007/s40262-015-0271-5.

    PubMed 25917876

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MDV3100 in people with Healthy Subjects and Pharmacokinetics of MDV3100, run by Astellas Pharma Europe B.V. 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 3 inclusion and 9 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 30 Jul 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?

Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by Maximum concentration (Cmax) (time frame: Day 1 through Day 78 (21 times)). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01911715, which also lists 1 linked publication.

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 30 Jul 2013.

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