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
Secondary identifying numbers D1050265
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

Study designOpen-label single dose oral administration study
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesPrimary 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) studiedRenal impairment
InterventionAll patients will receive a single oral 40 mg dose of lurasidone and be followed up for 7 days.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase I
Drug / device / biological / vaccine name(s)Lurasidone
Primary outcome measurePharmacokinetics 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 measuresSafety 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 study start date01/10/2008
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants24 - 27 patients (with renal impairment); minimum of 9 patients (control group); minimum of 33 (total study)
Key inclusion criteriaAll 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 criteria1. 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 enrolment01/10/2008
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • Czech Republic
  • England
  • Germany
  • United Kingdom

Study participating centre

Dainippon Sumitomo Pharma Europe Ltd
London
SE1E 6QT
United Kingdom

Sponsor information

Dainippon Sumitomo Pharma Europe Ltd (UK)
Industry

1st Floor, Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom

Website http://www.ds-pharma.co.jp/english
ROR logo "ROR" https://ror.org/03sh4z743

Funders

Funder type

Industry

Dainippon Sumitomo Pharma Co Ltd (Japan)
Private sector organisation / For-profit companies (industry)
Alternative name(s)
Dainippon Sumitomo Pharma Co., Ltd.
Location
Japan

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan