Hepatic impairment Digestive System Hepatic failure, not elsewhere classified
Conditions
Interventions
All patients will receive a single oral 20 mg dose of lurasidone and be followed up for 9 days.
Sponsors
Dainippon Sumitomo Pharma Europe Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Primary
| Measure | Time frame |
|---|---|
| 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 ?z, collected once at the completion of the trial, using data from blood samples collected from dosing up to 168 hours post-dose | — |
Countries
Czech Republic, Slovakia
Outcome results
None listed