Healthy SubjectsPhase 1NCT01911741
A Study to Compare Capsule and Tablet Forms of MDV3100 (Enzalutamide) After Administration of a Single Set Dose Under Fasted Conditions in Healthy Male Subjects
A Phase 1 study testing MDV3100 in people with Healthy Subjects and Castration Resistant Prostate Cancer (CRPC), run by Astellas Pharma Europe B.V. at 1 site in Germany.
Trial summary
A study to evaluate the bioavailability (BA) of a single oral dose of MDV3100 (enzalutamide) formulated as a solid spray dried tablet compared to oral liquid-filled capsules, and the safety and tolerability of oral formulations. 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, Castration Resistant Prostate Cancer (CRPC), Relative Bioavailability
- 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
- 55 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2012to Mar 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject has a body mass index (BMI) range of 18.5 - 29.9 kg/m2, inclusive. The subject weighs at least 50 kg (screening).
- Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 3 months after final study drug administration.
- Male subject must not donate sperm starting at screening and throughout the study period and for at least 3 months after final study drug administration.
Who cannot join
- Known or suspected hypersensitivity to enzalutamide, or any components of the formulation used.
- Confirmed CYP2C8 poor metabolizer status based on genotyping analysis.
- Any history of seizure including a febrile seizure in childhood, loss of consciousness, transient ischemic attack, or any condition that may pre-dispose to seizure.
- The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to first clinic check in.
- Use of grapefruit or marmalade in the week prior to admission to the Clinical Unit, as reported by the subject.
- Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-center, Open-label, Randomized, Parallel, Relative Bioavailability Study Comparing a Capsule and Tablet Formulations of Enzalutamide Following a Single 160 mg Dose Under Fasted Conditions in Healthy Male Subjects
A study to evaluate the bioavailability (BA) of a single oral dose of MDV3100 (enzalutamide) formulated as a solid spray dried tablet compared to oral liquid-filled capsules, and the safety and tolerability of oral formulations.
Subjects are admitted to the clinic from days 1 to 5, followed by outpatient assessments up to Day 50. They return to the clinic for an end of study visit (ESV) 7-10 days after the last pharmacokinetic (PK) sampling or after early withdrawal.
- Conditions
- Healthy Subjects, Castration Resistant Prostate Cancer (CRPC), Relative Bioavailability, MDV3100
- Being tested
- MDV3100
- Keywords
- Phase I, Enzalutamide, Relative bioavailability of MDV3100, Immediate release oral formulation, Xtandi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDV3100Drug
Also called enzalutamide, Xtandi
Oral
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Single dose of 4 liquid-filled capsules of MDV3100 reference formulation Receives: Drug: MDV3100 |
| Treatment B | Experimental | Single dose of 2 tablets of MDV3100 formulation tablet B Receives: Drug: MDV3100 |
| Treatment C | Experimental | Single dose of 2 tablets of MDV3100 formulation tablet C Receives: Drug: MDV3100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions
AUC0-t (Area Under Curve from time zero to last quantifiable sample), AUC0-inf (AUC extrapolated to infinity), Cmax (Maximum concentration)
Measured: Day 1 through Day 50 (26 times)
Secondary outcomes (2)
Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions
AUC0-72h (AUC from time zero to 72h post dose), AUC0-t, AUC0-inf, %AUC (Percentage of AUC), Cmax, tmax (Time to attain Cmax), λz (Terminal elimination rate constant), t1/2 (Terminal elimination half life), (MPR) metabolites to parent ratio, MPR(molecular weight corrected [MWC]), %AUC, CL/F (apparent oral clearance), Vz/F (apparent volume of distribution)
Measured: Day 1 through Day 50 (26 times)
Safety and tolerability of oral formulations of enzalutamide
adverse events, physical examination, vital signs, clinical laboratory tests, 12-lead Electrocardiogram (ECG)
Measured: Screening through ESV (7-10 days after the last pharmacokinetic (PK) sampling or after early withdrawal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startNov 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medivation, Inc.
- Responsible party
- Sponsor
- Investigators
- Study Manager, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911741
- Sponsor's protocol ID
- 9785-CL-0010
- Other IDs
- 2012-002502-49
- Status last verified
- Jul 2013
- First submitted
- 26 Jul 2013
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-center, Open-label, Randomized, Parallel, Relative Bioavailability Study Comparing a Capsule and Tablet Formulations of Enzalutamide Following a Single 160 mg Dose Under Fasted Conditions in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01911741
- Acronym / sponsor ID
- 9785-CL-0010
- Conditions
- Healthy Subjects, Castration Resistant Prostate Cancer (CRPC), Relative Bioavailability, MDV3100
- Keywords
- Phase I, Enzalutamide, Relative bioavailability of MDV3100, Immediate release oral formulation, Xtandi
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Collaborators
- Medivation, Inc.
- Study start
- Nov 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 30 Jul 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.
A study to evaluate the bioavailability (BA) of a single oral dose of MDV3100 (enzalutamide) formulated as a solid spray dried tablet compared to oral liquid-filled capsules, and the safety and tolerability of oral formulations.
Subjects are admitted to the clinic from days 1 to 5, followed by outpatient assessments up to Day 50. They return to the clinic for an end of study visit (ESV) 7-10 days after the last pharmacokinetic (PK) sampling or after early withdrawal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: MDV3100Single dose of 4 liquid-filled capsules of MDV3100 reference formulation |
| Treatment B | Experimental | Drug: MDV3100Single dose of 2 tablets of MDV3100 formulation tablet B |
| Treatment C | Experimental | Drug: MDV3100Single dose of 2 tablets of MDV3100 formulation tablet C |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The subject has a body mass index (BMI) range of 18.5 - 29.9 kg/m2, inclusive. The subject weighs at least 50 kg (screening).
- Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 3 months after final study drug administration.
- Male subject must not donate sperm starting at screening and throughout the study period and for at least 3 months after final study drug administration.
Key exclusion criteria (6 listed)
- Known or suspected hypersensitivity to enzalutamide, or any components of the formulation used.
- Confirmed CYP2C8 poor metabolizer status based on genotyping analysis.
- Any history of seizure including a febrile seizure in childhood, loss of consciousness, transient ischemic attack, or any condition that may pre-dispose to seizure.
- The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to first clinic check in.
- Use of grapefruit or marmalade in the week prior to admission to the Clinical Unit, as reported by the subject.
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 |
|---|---|---|
| MDV3100Also: enzalutamide, XtandiOral | Drug | Treatment A, Treatment B, Treatment C |
Primary outcome
Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions
Time frame: Day 1 through Day 50 (26 times)
AUC0-t (Area Under Curve from time zero to last quantifiable sample), AUC0-inf (AUC extrapolated to infinity), Cmax (Maximum concentration)
2 secondary outcomes
Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions
Time frame: Day 1 through Day 50 (26 times)
Safety and tolerability of oral formulations of enzalutamide
Time frame: Screening through ESV (7-10 days after the last pharmacokinetic (PK) sampling or after early withdrawal)
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 30 Jul 2013.
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Healthy Participants
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.
Study Manager study chair
Astellas Pharma Europe B.V.
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 MDV3100 in people with Healthy Subjects and Castration Resistant Prostate Cancer (CRPC), run by Astellas Pharma Europe B.V. at 1 site in Germany.
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 6 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 Germany. 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?
Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions (time frame: Day 1 through Day 50 (26 times)). 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 30 Jul 2013.