Condition category
Urological and Genital Diseases
Date applied
22/10/2008
Date assigned
19/02/2009
Last edited
19/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Shelda Alcock

ORCID ID

Contact details

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

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

http://www.ds-pharma.co.jp/english

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

Publication citations

Additional files

Editorial Notes