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

ISRCTN	ISRCTN62952643
DOI	https://doi.org/10.1186/ISRCTN62952643
Secondary identifying numbers	D1050264

Submission date: 29/01/2009
Registration date: 20/04/2009
Last edited: 30/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

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
SW1E 6QT
United Kingdom

Study information

Study design	Open-label phase I single dose non-randomised oral administration study
Primary study design	Interventional
Secondary study design	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	The effect of varying degrees of hepatic impairment on the single dose safety and pharmacokinetic profile of lurasidone: an open-label phase I single dose non-randomised oral administration study
Study objectives	Primary: to assess the effect of varying degrees of hepatic impairment on the pharmacokinetics of lurasidone Secondary: to assess the effect of varying degrees of hepatic impairment on the safety of lurasidone
Ethics approval(s)	1. Czech Republic: Ethics Committee for Clinical and Experimental Medicine and Faculty Thomayer Hospital approved 6th November 2008 2. Slovak Republic: Ethics Committee FNsP Bratislava approved 28th October 2008
Health condition(s) or problem(s) studied	Hepatic impairment
Intervention	All patients will receive a single oral 20 mg dose of lurasidone and be followed up for 9 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, calculated once at the completion of the trial, using data from blood samples collected from dosing up to 168 hours post-dose 2. Secondary parameters: AUC0-8, CL/F, tmax, t½, Vz/ F and λz, collected once at the completion of the trial, using data from blood samples collected from dosing up to 168 hours post-dose
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 including coagulation, and urinalysis) 3. Concomitant medication review 4. Vital sign assessments (supine blood pressure, heart rate, and body temperature) 5. 12-lead ECG 6. Complete physical examinations Collected once at the completion of the trial, using data from blood samples collected from dosing up to 168 hours post-dose.
Overall study start date	12/11/2008
Completion date	31/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	15 - 18 patients with hepatic impairment; 6 healthy subjects; minimum 21 in study
Key inclusion criteria	Main criteria: 1. Subject is male or female 2. Subject is between 18 to 75 years of age, inclusive 3. Body mass index (BMI) between 18 to 34 kg/m^2, inclusive, and a minimum body weight of 50 kg 4. Subject is informed of the nature of the study and has given written consent prior to initiating any study procedure 5. Subjects able to comply with all aspects of the protocol Hepatic impairment subjects: 6. Subjects with Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment 7. Subject's hepatic disease is deemed stable by the Investigator 8. Subject's pre-study clinical laboratory findings are within normal range or if outside of the normal range, deemed associated with underlying hepatic dysfunction or not clinically significant in the opinion of the Investigator Normal hepatic function subjects: 9. Subject is considered to be in good health in the opinion of the Investigator, as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and standard laboratory tests
Key exclusion criteria	1. Subject has had a clinically significant intercurrent illness in the four weeks before screening 2. Subject shows evidence of a clinically significant underlying medical condition, that, in the opinion of the Investigator, would represent a risk of study participation 3. History of or suspicion of significant gastrointestinal bleeding within the preceding 2 months 4. Any disorder (other than hepatic impairment, appendectomy, and cholecystectomy) that may alter the absorption, distribution, metabolism or excretion of drugs 5. History of clinically significant drug allergy including a history of atopic allergy (asthma, urticaria, or eczematous dermatitis) 6. Pregnant or lactating female subjects
Date of first enrolment	12/11/2008
Date of final enrolment	31/03/2009

Locations

Countries of recruitment

Czech Republic
England
Slovakia
United Kingdom

Study participating centre

Dainippon Sumitomo Pharma Europe Ltd

London
SW1E 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"	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 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