Healthy SubjectsPhase 1NCT01913379
Drug-drug Interaction Study With MDV3100 (ASP9785) and Gemfibrozil and Itraconazole
A Phase 1 study testing MDV3100, Gemfibrozil and Itraconazole in people with Healthy Subjects and Pharmacokinetics, run by Astellas Pharma Europe B.V. at 1 site in France.
Trial summary
A study to assess possible drug-drug interactions between MDV3100 and gemfibrozil and MDV3100 and Itraconazole. 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, Drug-Drug Interaction
- What is being tested?
- MDV3100, Gemfibrozil and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2011to Dec 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 weight of at least 65.0 kg and no greater than 85.0 kg.
- Body Mass Index (BMI) of at least 18.5 and no greater than 30.0 kg/m2.
Who cannot join
- Known or suspected hypersensitivity to MDV3100, itraconazole, gemfibrozil, any components of the formulations used, or any history of liver toxicity with other drugs.
- Confirmed CYP2C8 PM status based on genotyping analysis.
- Any of the liver function tests above the upper limit of normal. A retest to confirm the result may be performed once.
- History of seizure, including any febrile seizure, loss of consciousness, or transient ischemia attack within 12 months prior to enrollment (Day 1 visit), or any condition that may pre-dispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization).
- 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 (BP) measurements at the pre-study visit as follows: Pulse <40 or >90 bpm; mean systolic BP >140 mmHg ; mean diastolic BP >90 mmHg (BP measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically).
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- 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).
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Randomized, Open-label, 3-arm Parallel-design Study to Determine the Effect of Multiple-dose Gemfibrozil or Itraconazole on the Pharmacokinetics, Safety and Tolerability of Single-dose MDV3100 (ASP9785) in Healthy Male Subjects
A study to assess possible drug-drug interactions between MDV3100 and gemfibrozil and MDV3100 and Itraconazole.
- Conditions
- Healthy Subjects, Pharmacokinetics, Drug-Drug Interaction
- Being tested
- MDV3100, Gemfibrozil, Itraconazole
- Keywords
- Phase 1, MDV3100, Gemfibrozil, Itraconazole, Xtandi, enzalutamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDV3100Drug
Also called ASP9785, Xtandi, enzalutamide
Oral
GemfibrozilDrug
Oral
ItraconazoleDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1: MDV3100 | Experimental | Not described Receives: Drug: MDV3100 |
| 2: MDV3100 and gemfibrozil | Experimental | Not described Receives: Drug: MDV3100; Drug: Gemfibrozil |
| 3: MDV3100 and itraconazole | Experimental | Not described Receives: Drug: MDV3100; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pharmacokinetic profile of MDV3100 by Cmax (Maximum concentration)
Measured: Day 1 through Day 53 (29 times)
Assessment of pharmacokinetic profile of MDV3100 by AUCinf (AUC extrapolated to infinity)
Measured: Day 1 through Day 53 (29 times)
Assessment of pharmacokinetic profile of MDV3100 by AUC0-432h (AUC from the time of dosing to 432 hours post-dose)
Measured: Day 1 through Day 53 (29 times)
Secondary outcomes (6)
Assessment of pharmacokinetic profile of MDV3100
tmax (Time to attain Cmax), t1/2 (Apparent terminal elimination half life), Vz/F (Apparent volume of distribution during the terminal phase after extra vascular dosing) and CL/F(Apparent total body clearance after extra vascular dosing)
Measured: Day 1 through Day 53 (29 times)
Assessment of pharmacokinetic profile of the metabolites MDPC0001 and MDPC0002
Cmax, AUC0-432h, tmax, t1/2, and AUC0-inf
Measured: Day 1 through Day 53 (29 times)
Assessment of metabolite-to-parent ratios for MDV3100
This may additionally be reported to assess effects on particular enzyme pathways
Measured: Day 1 through Day 53 (29 times)
Assessment of Gemfibrozil and gemfibrozil 1-O-β-glucuronide (Arm 2)
Cmax, C0h, Cmin, tmax, AUCtau
Measured: Day 1 through Day 53 (50 times)
Assessment of itraconazole and hydroxyitraconazole (Arm 3)
Cmax, C0h, Cmin, tmax, AUCtau
Measured: Day 1 through Day 53 (50 times)
Safety as assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs)
In arm 3, liver function tests (AST, ALT, GGT, total bilirubin) will be done regularly during itraconazole dosing
Measured: Day 1 through Day 53
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 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
- Operation Senior Research Manager, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913379
- Sponsor's protocol ID
- 9785-CL-0006
- Other IDs
- 2011-000333-37
- Status last verified
- Jul 2013
- First submitted
- 30 Jul 2013
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gibbons JA, de Vries M, Krauwinkel W, Ohtsu Y, Noukens J, van der Walt JS, Mol R, Mordenti J, Ouatas T. Pharmacokinetic Drug Interaction Studies with Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1057-69. doi: 10.1007/s40262-015-0283-1.
PubMed 25929560
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Open-label, 3-arm Parallel-design Study to Determine the Effect of Multiple-dose Gemfibrozil or Itraconazole on the Pharmacokinetics, Safety and Tolerability of Single-dose MDV3100 (ASP9785) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01913379
- Acronym / sponsor ID
- 9785-CL-0006
- Conditions
- Healthy Subjects, Pharmacokinetics, Drug-Drug Interaction
- Keywords
- Phase 1, MDV3100, Gemfibrozil, Itraconazole, Xtandi, enzalutamide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Collaborators
- Medivation, Inc.
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Aug 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 assess possible drug-drug interactions between MDV3100 and gemfibrozil and MDV3100 and Itraconazole.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1: MDV3100 | Experimental | Drug: MDV3100 |
| 2: MDV3100 and gemfibrozil | Experimental | Drug: MDV3100, Drug: Gemfibrozil |
| 3: MDV3100 and itraconazole | Experimental | Drug: MDV3100, Drug: Itraconazole |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body weight of at least 65.0 kg and no greater than 85.0 kg.
- Body Mass Index (BMI) of at least 18.5 and no greater than 30.0 kg/m2.
Key exclusion criteria (9 listed)
- Known or suspected hypersensitivity to MDV3100, itraconazole, gemfibrozil, any components of the formulations used, or any history of liver toxicity with other drugs.
- Confirmed CYP2C8 PM status based on genotyping analysis.
- Any of the liver function tests above the upper limit of normal. A retest to confirm the result may be performed once.
- History of seizure, including any febrile seizure, loss of consciousness, or transient ischemia attack within 12 months prior to enrollment (Day 1 visit), or any condition that may pre-dispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization).
- Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever).
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: ASP9785, Xtandi, enzalutamideOral | Drug | 1: MDV3100, 2: MDV3100 and gemfibrozil, 3: MDV3100 and itraconazole |
| GemfibrozilOral | Drug | 2: MDV3100 and gemfibrozil |
| ItraconazoleOral | Drug | 3: MDV3100 and itraconazole |
Primary outcome
Assessment of pharmacokinetic profile of MDV3100 by Cmax (Maximum concentration)
Time frame: Day 1 through Day 53 (29 times)
Assessment of pharmacokinetic profile of MDV3100 by AUCinf (AUC extrapolated to infinity)
Time frame: Day 1 through Day 53 (29 times)
Assessment of pharmacokinetic profile of MDV3100 by AUC0-432h (AUC from the time of dosing to 432 hours post-dose)
Time frame: Day 1 through Day 53 (29 times)
6 secondary outcomes
Assessment of pharmacokinetic profile of MDV3100
Time frame: Day 1 through Day 53 (29 times)
Assessment of pharmacokinetic profile of the metabolites MDPC0001 and MDPC0002
Time frame: Day 1 through Day 53 (29 times)
Assessment of metabolite-to-parent ratios for MDV3100
Time frame: Day 1 through Day 53 (29 times)
Assessment of Gemfibrozil and gemfibrozil 1-O-β-glucuronide (Arm 2)
Time frame: Day 1 through Day 53 (50 times)
Assessment of itraconazole and hydroxyitraconazole (Arm 3)
Time frame: Day 1 through Day 53 (50 times)
Safety as assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs)
Time frame: Day 1 through Day 53
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 1 Aug 2013.
- Derived from this study: PubMed 25929560Gibbons JA, de Vries M, Krauwinkel W, Ohtsu Y, Noukens J, van der Walt JS, Mol R, Mordenti J, Ouatas T. Pharmacokinetic Drug Interaction Studies with Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1057-69. doi: 10.1007/s40262-015-0283-1.
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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.
Operation Senior Research 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, Gemfibrozil and Itraconazole in people with Healthy Subjects and Pharmacokinetics, run by Astellas Pharma Europe B.V. at 1 site in France.
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 2 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 1 Aug 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 France. 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 MDV3100 by Cmax (Maximum concentration) (time frame: Day 1 through Day 53 (29 times)). The study lists 3 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 NCT01913379, 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 1 Aug 2013.