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

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Astellas

Status and phase

Completed
Phase 1

Conditions

Drug-Drug Interaction
Healthy Subjects
Pharmacokinetics

Treatments

Drug: Gemfibrozil
Drug: Itraconazole
Drug: MDV3100

Study type

Interventional

Funder types

Industry

Identifiers

NCT01913379
9785-CL-0006
2011-000333-37 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

41 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

41 participants in 3 patient groups

1: MDV3100
Experimental group
Treatment:
Drug: MDV3100
2: MDV3100 and gemfibrozil
Experimental group
Treatment:
Drug: MDV3100
Drug: Gemfibrozil
3: MDV3100 and itraconazole
Experimental group
Treatment:
Drug: MDV3100
Drug: Itraconazole

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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