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This study has been completed.
Information provided by (Responsible Party):
Sunovion Identifier:
First received: March 5, 2010
Last updated: April 1, 2014
Last verified: April 2014
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
Drug: Lurasidone
Phase 1

Study Type: Interventional
Study Design: 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 ]
  • To determine the whole blood and serum concentrations of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci). [ Time Frame: 28 days ]
  • To determine the urinary and fecal recovery of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci). [ Time Frame: 28 days ]

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

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
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.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01082146

United States, Wisconsin
Covance Global Clinical Research Unit Inc.
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Principal Investigator: John Bohn, MD Covance Global Clinical Research Unit Inc.
  More Information

Responsible Party: Sunovion Identifier: NCT01082146     History of Changes
Other Study ID Numbers: D1050262
Study First Received: March 5, 2010
Last Updated: April 1, 2014

Keywords provided by Sunovion:
pharmacokinetics, lurasidone

Additional relevant MeSH terms:
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents processed this record on April 28, 2017