ISRCTN16720571
Completed
Not Applicable
The effect of varying degrees of renal impairment on the single dose pharmacokinetic profile of orally administered lurasidone: a phase I study
Dainippon Sumitomo Pharma Europe Ltd (UK)0 sites33 target enrollmentFebruary 19, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Renal impairment
- Sponsor
- Dainippon Sumitomo Pharma Europe Ltd (UK)
- Enrollment
- 33
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All subjects:
- •1\. Male or female, between 18 and 75 years of age inclusive
- •2\. Body mass index (BMI) between 18 and 32 kg/m^2, and minimum body weight of 50 kg
- •3\. Written informed consent
- •4\. Able to comply with all aspects of protocol
- •Renal impairment subjects:
- •5\. Renal impairment based on Cockcroft\-Gault estimation of creatinine clearance (CrCl)
- •6\. Renal disease is deemed stable by investigator
- •7\. Pre\-study clinical laboratory findings are within normal range
- •Normal renal function subjects:
Exclusion Criteria
- •1\. Clinically significant illness in 4 weeks before screening
- •2\. Shows evidence of clinical significant underlying medical condition
- •3\. End\-stage renal disease and is receiving dialysis
- •4\. Any disorder which may alter drug absorption, distribution, metabolism and excretion
Outcomes
Primary Outcomes
Not specified
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