Renal impairment Urological and Genital Diseases Renal impairment
Conditions
Interventions
All patients will receive a single oral 40 mg dose of lurasidone and be followed up for 7 days.
Sponsors
Dainippon Sumitomo Pharma Europe Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion 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: 8. Subject has normal renal function based on Cockcroft-Gault estimation 9. Subject is in good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG) and standard laboratory tests
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics will be assessed as follows: 1. Primary parameters: AUC0-last, Cmax, assessed by PK sampling at 15 timepoints from 0 - 96 hours post-dose 2. Secondary parameters: AUC0-8, CL/F, tmax, t½, Vz/F and lambda z assessed at multiple timepoints until day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be assessed by using the following endpoints: 1. Spontaneous adverse event reporting 2. Clinical laboratory tests (clinical chemistry including prolactin, haematology and urinalysis) 3. Concomitant medication review 4. Vital sign assessments (supine blood pressure, heart rate, body temperature) 5. 12-lead ECG 6. Complete physical examinations | — |
Countries
Czech Republic, Germany
Outcome results
None listed