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
Scientific
Dainippon Sumitomo Pharma Europe Ltd
1st Floor, Southside
97-105 Victoria Street
London
SE1E 6QT
United Kingdom
Study information
| Study design | Open-label single dose oral administration study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Lurasidone |
| Primary outcome measure | 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 study start date | 01/10/2008 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 24 - 27 patients (with renal impairment); minimum of 9 patients (control group); minimum of 33 (total study) |
| 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
- Czech Republic
- England
- Germany
- United Kingdom
Study participating centre
Dainippon Sumitomo Pharma Europe Ltd
London
SE1E 6QT
United Kingdom
SE1E 6QT
United Kingdom
Sponsor information
Dainippon Sumitomo Pharma Europe Ltd (UK)
Industry
Industry
1st Floor, Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom
| Website | http://www.ds-pharma.co.jp/english |
|---|---|
"ROR" |
https://ror.org/03sh4z743 |
Funders
Funder type
Industry
Dainippon Sumitomo Pharma Co Ltd (Japan)
Private sector organisation / For-profit companies (industry)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
