Drug Interaction Study to Asses Multiple Doses of ZD4054 (Zibotentan)

AstraZeneca12 enrolled

Overview

The purpose of the study is to to assess the effect of multiple oral doses of ZD4054 (Zibotentan) on the pharmacokinetics of a CYP450 3A Probe (midazolam) in healthy male subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

midazolamDRUG

ZD4054DRUG

ZD4054 10 mg od

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * BMI between 18 and 30 kg/m2 * Medical and surgical history and physical examination without any clinically significant findings * Normal resting ECG with QTcB interval \<450ms Exclusion Criteria: * Definite or suspected personal history or family history of hypersensitivity to drugs that are endothelin antagonists; ie, ambrisentan, artrasentan, sitaxsetan and bosentan * Healthy volunteer has a known hypersensitivity to midazolam or any of the excipients of the midazolam tablet * Medical diagnosis of migraine with an attack during the 12 months prior to Screening

Locations (1)

Research Site

Berlin, Germany

Outcomes

Primary Outcomes

PK variables

Time frame: Frequent sampling occasions during study

Secondary Outcomes

Safety variables (adverse events, ECG, blood pressure, pulse, safety lab)

Time frame: During the whole treatment period

Data from ClinicalTrials.gov

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