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Drug-drug interaction study with MDV3100 and a cocktail of substrates

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01911728

Astellas Study ID

The unique identification code given by the study sponsor.

9785-CL-0007

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2011-000163-26

Follow Trial

Condition

Other, Prostate Cancer

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

18 years - N/A

Sex

Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jul 2011 - Feb 2012

Masking

None (Open Label)

Enrollment number

14

A Phase I open-label study to evaluate the effect of multiple doses of MDV3100 (ASP9785) on the pharmacokinetics of substrates for CYP2C8, CYP2C9, CYP2C19, and CYP3A4 in patients with castration-resistant prostate cancer

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Parexel/Qdot Pharma

Port Elizabeth, South Africa

Parexel

George, South Africa

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