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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lurasidone | Experimental | LURASIDONE 40mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurasidone | Drug | 40 mg suspension, PO, for 7 days |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Bohn, MD | Covance Global Clinical Research Unit Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Global Clinical Research Unit Inc. | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| D000069056 | Lurasidone Hydrochloride |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| 28 days |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |