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

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

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

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics; Metabolism
• Intervention / Treatment: Drug: Lurasidone

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Global Clinical Research Unit Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: March 5, 2010
• First Submitted That Met QC Criteria: March 5, 2010
• First Posted (Estimate): March 8, 2010

Study Record Updates

• Last Update Posted (Estimate): April 3, 2014
• Last Update Submitted That Met QC Criteria: April 1, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: pharmacokinetics, lurasidone
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Lurasidone Hydrochloride
• Other Study ID Numbers: D1050262