Drug-drug Interaction Study With MDV3100 (ASP9785) and Gemfibrozil and Itraconazole

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

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-12-31

Brief Summary

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A study to assess possible drug-drug interactions between MDV3100 and gemfibrozil and MDV3100 and Itraconazole.

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Detailed Description

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Conditions

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Healthy Subjects Pharmacokinetics Drug-Drug Interaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1: MDV3100

Group Type EXPERIMENTAL

MDV3100

Intervention Type DRUG

Oral

2: MDV3100 and gemfibrozil

Group Type EXPERIMENTAL

MDV3100

Intervention Type DRUG

Oral

Gemfibrozil

Intervention Type DRUG

Oral

3: MDV3100 and itraconazole

Group Type EXPERIMENTAL

MDV3100

Intervention Type DRUG

Oral

Itraconazole

Intervention Type DRUG

Oral

Interventions

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MDV3100

Oral

Intervention Type DRUG

Gemfibrozil

Oral

Intervention Type DRUG

Itraconazole

Oral

Intervention Type DRUG

Other Intervention Names

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ASP9785 Xtandi enzalutamide

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes