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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ZD4054; Drug: midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00709553

ZD4054EudraCt 2008-002764-35

D4320C00010

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

12 participants in 2 patient groups

1

Experimental group

Description:

midazolam, one single dose of 705mg

Treatment:

Drug: midazolam

2

Experimental group

Description:

ZD4054(Zibotentan)- 10mg od, 7 days + midazolam (one single dose of 7.5 mg on day 6 )

Treatment:

Drug: midazolam

Drug: ZD4054