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

ISRCTN	ISRCTN16720571
DOI	https://doi.org/10.1186/ISRCTN16720571
Protocol serial number	D1050265
Sponsor	Dainippon Sumitomo Pharma Europe Ltd (UK)
Funder	Dainippon Sumitomo Pharma Co Ltd (Japan)

Submission date: 22/10/2008
Registration date: 19/02/2009
Last edited: 19/02/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Shelda Alcock
Scientific

Dainippon Sumitomo Pharma Europe Ltd
1st Floor, Southside
97-105 Victoria Street
London
SE1E 6QT
United Kingdom

Study information

Primary study design	Interventional
Study design	Open-label single dose oral administration study
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	Primary hypothesis: To assess the effect of varying degrees of renal impairment on the pharmacokinetics of lurasidone and its major metabolites. Secondary hypothesis: To assess the effect of varying degrees of renal impairment on the safety of lurasidone and its major metabolites.
Ethics approval(s)	1. Germany: Medical Association of Saxony gave approval on the 29th August 2008 2. Czech Republic: Ethics Committee for Multi-Centric Clinical Trial of the University Hospital Motol gave approval on the 23rd September 2008
Health condition(s) or problem(s) studied	Renal impairment
Intervention	All patients will receive a single oral 40 mg dose of lurasidone and be followed up for 7 days.
Intervention type	Drug
Phase	Phase I
Drug / device / biological / vaccine name(s)	Lurasidone
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	33
Key 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
Key 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
Date of first enrolment	01/10/2008
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

United Kingdom
England
Czech Republic
Germany

Study participating centre

Dainippon Sumitomo Pharma Europe Ltd

London
SE1E 6QT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes