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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 22, 2014