We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01082146
Recruitment Status : Completed
First Posted : March 8, 2010
Last Update Posted : April 3, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Pharmacokinetics Metabolism Drug: Lurasidone Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2008
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Lurasidone
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Lurasidone
LURASIDONE 40mg
Drug: Lurasidone
40 mg suspension, PO, for 7 days


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. To determine the whole blood and serum concentrations of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci). [ Time Frame: 28 days ]
  3. To determine the urinary and fecal recovery of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci). [ Time Frame: 28 days ]

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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01082146     History of Changes
Other Study ID Numbers: D1050262
First Posted: March 8, 2010    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: April 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