Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
D1050264
Study information
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
Acronym
Study hypothesis
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
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
Study design
Open-label phase I single dose non-randomised oral administration study
Primary study design
Interventional
Secondary study design
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
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
Phase
Phase I
Drug names
Lurasidone
Primary outcome measures
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 trial start date
12/11/2008
Overall trial end date
31/03/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
15 - 18 patients with hepatic impairment; 6 healthy subjects; minimum 21 in study
Participant 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
Recruitment start date
12/11/2008
Recruitment end date
31/03/2009
Locations
Countries of recruitment
Czech Republic, Slovakia
Trial participating centre
Dainippon Sumitomo Pharma Europe Ltd
London
SW1E 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