NCT00863161CompletedPhase 1
A Phase I, Open Label, Non-randomized, Parallel Group, Pharmacokinetic Study in Subjects With Normal Renal Function, Moderate or Severe Renal Impairment Receiving a Single Dose of Oral 130 mg AZD3355
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Pharmacokinetic blood samples
Study Overview
Brief Summary
The purpose of this study is to see how quickly AZD3355 is taken up in to the blood and leaves the blood in people with normal kidney function or with different degrees of reduced kidney function.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Provision of signed informed consent
- •Subjects should have either normal renal function or have a moderate renal impairment or severe renal impairment
Exclusion Criteria
- •History of heart disease
- •Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder
Arms & Interventions
1
Experimental
AZD3355 65 + 65 mg capsule
Intervention: AZD3355 (Drug)
Outcomes
Primary Outcomes
Pharmacokinetic blood samples
Time Frame: 15 samples during 0-72 hours
Secondary Outcomes
- Pharmacokinetic urine samples(8 samples during 72 hours)
Investigators
Study Sites (2)
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