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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01082146
• Other study ID #: D1050262
• Status: Completed
• Phase: Phase 1
• First received: March 5, 2010
• Last updated: April 1, 2014
• Start date: August 2008
• Est. completion date: August 2008

Study information

• Verified date: April 2014
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Metabolism
• Pharmacokinetics

Intervention

Drug:
• Lurasidone
40 mg suspension, PO, for 7 days

Locations

Country	Name	City	State
United States	Covance Global Clinical Research Unit Inc.	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	To determine the whole blood and serum concentrations of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci).		28 days	No
Primary	To determine the urinary and fecal recovery of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci).		28 days	No
Secondary	To assess the safety of 40 mg [Isothiazolyl-3-14C]-Lurasidone		28 days	Yes
Secondary	To characterize and identify metabolites of Lurasidone in serum and urine		28 days	Yes
Secondary	To determine serum concentrations of Lurasidone		28 days	Yes