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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01082146
First received: March 5, 2010
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Pharmacokinetics
Metabolism
Drug: Lurasidone
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • 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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • To determine the whole blood and serum concentrations of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci). [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • To determine the urinary and fecal recovery of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci). [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety of 40 mg [Isothiazolyl-3-14C]-Lurasidone [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • To characterize and identify metabolites of Lurasidone in serum and urine [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • To determine serum concentrations of Lurasidone [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: August 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lurasidone
LURASIDONE 40mg
Drug: Lurasidone
40 mg suspension, PO, for 7 days

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082146

Locations
United States, Wisconsin
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.
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01082146     History of Changes
Other Study ID Numbers: D1050262
Study First Received: March 5, 2010
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
pharmacokinetics, lurasidone

ClinicalTrials.gov processed this record on April 17, 2014