Renal Impairment
Conditions
Keywords
AZD5672
Brief summary
The purpose of the study is to investigate the pharmacokinetics of a single dose of AZD5672 in patients with renal impairment by comparing with healthy volunteers
Interventions
DRUGAZD5672
100 mg oral single dose
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Provision of signed written informed consent. * Females should not be of childbearing potential * Subjects classified as renally impaired should have been stable (in the Investigator's opinion) for at least 3 months prior to Visit 1.
Exclusion criteria
* Patients taking prescription of medications: Pgp substrates, inhibitors and /or inducers, medications that affect creatinine clearance(within 7 days of dosing), atorvastatin \>20mg once daily, medications that prolong QT/QTc interval * Change in dose regimen of prescribed medication and NSAIDs within the 2 weeks before enrolment (renal patients only) * Participation in another clinical study involving administration of an investigational product in the 3 months prior to treatment (or within 5 half-lives of the last dose of the investigational product, whichever is longer)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK variables | Frequent sampling occasions during study period |
Secondary
| Measure | Time frame |
|---|---|
| Safety variables (adverse events, blood pressure, pulse, safety lab) | During the treatment period |
Countries
Germany
Outcome results
None listed