RI-AME Study OF [ISOTHIAZOLYL-3-14C]-LURASIDONE

Sumitomo Pharma

Status and phase: Completed; Phase 1

Conditions: Metabolism; Pharmacokinetics

Treatments: Drug: Lurasidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01082146

D1050262

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

6 participants in 1 patient group

Lurasidone

Experimental group

Description:

LURASIDONE 40mg

Treatment:

Drug: Lurasidone