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

Phase 1

Completed

• Conditions: Metabolism; Pharmacokinetics
• Interventions: Drug: Lurasidone

• Registration Number: NCT01082146
• Lead Sponsor: Sumitomo Pharma America, Inc.

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.

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2010-03-05
• Study First Submitted QC: 2010-03-05
• Study First Posted: 2010-03-08
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-01
• Last Update Posted: 2014-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lurasidone	Lurasidone	LURASIDONE 40mg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Covance Global Clinical Research Unit Inc.; 🇺🇸 Madison, Wisconsin, United States