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

• Sponsor: Sunovion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01082146
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics; Metabolism	Drug: Lurasidone	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [Issthiazolyl-3-14C]-Lurasidone Following Postprandial Single Oral Dose Administration in Health Male Subjects
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lurasidone LURASIDONE 40mg	Drug: Lurasidone; 40 mg suspension, PO, for 7 days

Outcome Measures

Primary Outcome Measures

1. 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]

2. To determine the whole blood and serum concentrations of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci). [28 days]

3. To determine the urinary and fecal recovery of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci). [28 days]

Secondary Outcome Measures

1. To assess the safety of 40 mg [Isothiazolyl-3-14C]-Lurasidone [28 days]

2. To characterize and identify metabolites of Lurasidone in serum and urine [28 days]

3. To determine serum concentrations of Lurasidone [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Global Clinical Research Unit Inc.	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

• Sunovion

Investigators

• Principal Investigator: John Bohn, MD, Covance Global Clinical Research Unit Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sunovion
• ClinicalTrials.gov Identifier: NCT01082146
• Other Study ID Numbers: D1050262
• First Posted: Mar 8, 2010
• Last Update Posted: Apr 3, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Sunovion: pharmacokinetics, lurasidone
• Additional relevant MeSH terms: Lurasidone Hydrochloride

Study Results

No Results Posted as of Apr 3, 2014