Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
D1050265
Study information
Scientific title
Acronym
Study hypothesis
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
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
Study design
Open-label single dose oral administration study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Lurasidone
Primary outcome measures
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 outcome measures
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
Overall trial start date
01/10/2008
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
24 - 27 patients (with renal impairment); minimum of 9 patients (control group); minimum of 33 (total study)
Participant 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
Recruitment start date
01/10/2008
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Czech Republic, Germany
Trial participating centre
Dainippon Sumitomo Pharma Europe Ltd
London
SE1E 6QT
United Kingdom
Sponsor information
Organisation
Dainippon Sumitomo Pharma Europe Ltd (UK)
Sponsor details
1st Floor
Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Dainippon Sumitomo Pharma Co Ltd (Japan)
Alternative name(s)
Dainippon Sumitomo Pharma Co., Ltd.
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
Japan
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary