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Drug-drug Interaction Study With MDV3100 and a Cocktail of Substrates

NCT01911728 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-06-26

No results posted yet for this study

Summary

A drug-drug interaction study to investigate the potential pharmacokinetic interaction between MDV3100 and a cocktail of substrates for pioglitazone (CYP2C8 substrate), S-warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and midazolam (CYP3A4 substrate).

Conditions

  • Pharmacokinetics of MDV3100
  • Castration Resistant Prostate Cancer (CRPC)

Interventions

DRUG

MDV3100

Oral

DRUG

Pioglitazone

Oral

DRUG

Warfarin

Oral

DRUG

Omeprazole

Oral

DRUG

Midazolam

Oral

Sponsors & Collaborators

  • Medivation, Inc.

    collaborator INDUSTRY

  • Astellas Pharma Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Operation Senior Research Manager · Astellas Pharma Europe B.V.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-25
Primary Completion
2012-02-21
Completion
2012-02-21

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01911728 on ClinicalTrials.gov