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

NCT ID: NCT01082146

Last Updated: 2014-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2008-08-31

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.

Conditions

Pharmacokinetics; Metabolism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Lurasidone

LURASIDONE 40mg

Group Type: EXPERIMENTAL

Lurasidone

Intervention Type: DRUG

40 mg suspension, PO, for 7 days

Interventions

Lurasidone

40 mg suspension, PO, for 7 days

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Bohn, MD

Role: PRINCIPAL_INVESTIGATOR

Covance Global Clinical Research Unit Inc.

Locations

Covance Global Clinical Research Unit Inc.

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

D1050262

Identifier Type: -

Identifier Source: org_study_id