Metabolism, Pharmacokinetics
Conditions
Keywords
pharmacokinetics, lurasidone
Brief summary
This will be an open-label, non-randomized, absorption, metabolism, and excretion study of Lurasidone administered in a suspension at 40 mg to 6 normal healthy male subjects in a postprandial state
Detailed description
A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of \[Isothiazolyl-3-14C\]-Lurasidone Following Postprandial Single Oral Dose Administration in Healthy Male Subjects.
Interventions
DRUGLurasidone
40 mg suspension, PO, for 7 days
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. within a BMI range of 18.0 to 28.0 kg/m2 inclusive; 2. males will either be sterile or agree to use from Check-in until 45 days following Study Completion/Discharge approved methods of contraception 3. able to comprehend and willing to sign an Informed Consent Form (ICF); 4. able to void urine on a daily basis and 1 to 2 bowel movements per day. 5. able to swallow 60 mL of dosing suspension.
Exclusion criteria
1. history or presence of an abnormal ECG 2. participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in. 3. exposure to significant radiation within 12 months prior to Check-in; 4. participation in any other investigational study drug trial 5. use of any prescription medications/products within 14 days prior to Check-in 6. use of any inhibitors or inducers of CYP3A4 taken within 30 days prior to Check-in, including but not limited to drugs listed in Appendix E; 7. receipt of blood products within 2 months prior to Check-in;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the pharmacokinetics (PK) of a postprandial single dose of 40 mg (150 Ci 5.55 Megabecquerels (MBq)) [Isothiazolyl-3-14C-Lurasidone and its metabolites | 28 days |
| To determine the whole blood and serum concentrations of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci). | 28 days |
| To determine the urinary and fecal recovery of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci). | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of 40 mg [Isothiazolyl-3-14C]-Lurasidone | 28 days |
| To characterize and identify metabolites of Lurasidone in serum and urine | 28 days |
| To determine serum concentrations of Lurasidone | 28 days |
Countries
United States
Outcome results
None listed