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

NCT01082146 | Completed Phase 1 DMC

• 1 other identifier: D1050262
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Pharmacokinetics; Metabolism

Keywords

pharmacokinetics, lurasidone

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (1)

Lurasidone

EXPERIMENTAL

LURASIDONE 40mg

Drug: Lurasidone

Interventions

Lurasidone DRUG

40 mg suspension, PO, for 7 days

Lurasidone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• within a BMI range of 18.0 to 28.0 kg/m2 inclusive;
• males will either be sterile or agree to use from Check-in until 45 days following Study Completion/Discharge approved methods of contraception
• able to comprehend and willing to sign an Informed Consent Form (ICF);
• able to void urine on a daily basis and 1 to 2 bowel movements per day.
• able to swallow 60 mL of dosing suspension.

You may not qualify if:

• history or presence of an abnormal ECG
• participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in.
• exposure to significant radiation within 12 months prior to Check-in;
• participation in any other investigational study drug trial
• use of any prescription medications/products within 14 days prior to Check-in
• 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;
• receipt of blood products within 2 months prior to Check-in;

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (1)

Covance Global Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

Lurasidone Hydrochloride

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• John Bohn, MD

  Covance Global Clinical Research Unit Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 8, 2010
• Study Start: August 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 3, 2014

Record last verified: 2014-04

Locations

US (1)