Healthy
Conditions
Keywords
ZD4054, Healthy Volunteers
Brief summary
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.
Interventions
DRUGmidazolam
DRUGZD4054
ZD4054 10 mg od
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK variables | Frequent sampling occasions during study |
Secondary
| Measure | Time frame |
|---|---|
| Safety variables (adverse events, ECG, blood pressure, pulse, safety lab) | During the whole treatment period |
Countries
Germany
Outcome results
None listed