The effect of varying degrees of renal impairment on the single dose pharmacokinetic profile of orally administered lurasidone: a phase I study

Completed

Conditions: Renal impairment
Urological and Genital Diseases

Registration Number: ISRCTN16720571

Lead Sponsor: Dainippon Sumitomo Pharma Europe Ltd (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 33

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics will be assessed as follows:<br>1. Primary parameters: AUC0-last, Cmax, assessed by PK sampling at 15 timepoints from 0 - 96 hours post-dose<br>2. Secondary parameters: AUC0-8, CL/F, tmax, t½, Vz/F and lambda z assessed at multiple timepoints until day 7

Secondary Outcome Measures

Name	Time	Method
Safety will be assessed by using the following endpoints:<br>1. Spontaneous adverse event reporting<br>2. Clinical laboratory tests (clinical chemistry including prolactin, haematology and urinalysis)<br>3. Concomitant medication review<br>4. Vital sign assessments (supine blood pressure, heart rate, body temperature)<br>5. 12-lead ECG<br>6. Complete physical examinations