The Bioequivalence Of Two Different Lurasidone Formulations In Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01082250
First received: March 5, 2010
Last updated: September 6, 2011
Last verified: September 2011
  Purpose

A Phase I, Bioequivalent Study between 2 Formulations of Lurasidone HCl


Condition Intervention Phase
Schizophrenia
Drug: Lurasidone HCl
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: AN OPEN-LABEL, RANDOMIZED, THREE-PERIOD, TWO-SEQUENCE CROSSOVER, REPEATED-DOSE, REPLICATE DESIGN STUDY TO DETERMINE THE BIOEQUIVALENCE OF TWO DIFFERENT LURASIDONE FORMULATIONS IN PATIENTS WITH SCHIZOPHRENIA, SCHIZOAFFECTIVE, OR SCHIZOPHRENIFORM DISORDER

Resource links provided by NLM:


Further study details as provided by Sunovion:

Estimated Enrollment: 52
Study Start Date: July 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Reference Formulation
Dosed 12.5% drugload 3X40mg
Drug: Lurasidone HCl
120mg dose. 3-way cross-over for 21 days
Test Formulation
25% Drugload 1X120mg
Drug: Lurasidone HCl
120mg dose. 3-way cross-over for 21 days

Detailed Description:

12.5% Drugload 3X40mg vs. 25% Drugload 1X120mg

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorders as per DSM-IV or DSM-IV-TR criteria, which in the opinion of the investigator have been clinically stable for the past 6 months.
  2. Body mass index (BMI) ≥ 19.5 and ≤ 37 kg/m2.
  3. No clinically relevant abnormal laboratory values.
  4. No clinically significant findings in the 12-lead electrocardiogram (ECG):
  5. No clinically significant findings from a vital signs measurement.
  6. Able to understand and provide written consent prior to initiating any study procedure after being informed of the nature of the study.
  7. Females who participate in this study:

    • are unable to have children (e.g. post-menopausal, tubal ligation, hysterectomy); OR
    • are willing to remain abstinent [not engage in sexual intercourse] from Day -5 until the final follow-up visit; OR
    • are willing to use an effective method of double-barrier birth control (e.g. partner using condom and female using diaphragm, contraceptive sponge, spermicide, or intrauterine device [IUD]) from Day -5 until the final follow-up visit.
  8. Males must be willing to remain sexually abstinent or use an effective method of birth control (e.g. condom) from Day -5 until the final follow-up visit.

Exclusion Criteria:

  1. Significant disease(s) or clinically significant finding(s) in a physical examination determined by an Investigator to pose a health concern to the patient while on study.
  2. Known history or presence of intolerance to psychiatric medications (e.g. atypical antipsychotic medications).
  3. History of alcohol or drug-dependence as per DSM-IV criteria during the 6-month period immediately prior to study entry.
  4. Significant orthostatic hypotension (i.e. a drop in systolic blood pressure of 30 mmHg or more and/or drop in diastolic blood pressure of 20 mmHg or more on standing).
  5. Presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
  6. A history of epilepsy or risk of having seizures.
  7. Positive test results within 30 days prior to the start of the study for:

    1. Human immunodeficiency virus (HIV).
    2. Hepatitis B surface antigen and Hepatitis C antibody.
    3. Urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
    4. Serum beta-HCG consistent with pregnancy (females only).
  8. Participated in another clinical trial or received an investigational product within 30 days prior to Screening.
  9. Use of any inhibitor or inducer of CYP3A4 taken within 30 days prior to check-in, including but not limited to those listed in Appendix 19.3.
  10. Difficulty fasting or consuming the standard meals.
  11. Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing.

    -OR- Females having used implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing.

  12. Donation or loss of whole blood prior to drug administration, as follows:

    1. ≤ 499 mL within 30 days prior to dosing
    2. ≥ 500 mL within 56 days prior to dosing.
  13. Patient has a prolactin concentration ≥ 100 ng/mL at Screening.
  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: NCT01082250

Locations
United States, California
California Clinical Trials (CCT)
Glendale, California, United States, 91206
Sponsors and Collaborators
Sunovion
Investigators
Principal Investigator: Lev Gertsik, MD California Clinical Trials (CCT)
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01082250     History of Changes
Other Study ID Numbers: D1050263
Study First Received: March 5, 2010
Last Updated: September 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Bioequivalence
Male/Female Patient
Reference/Test Formulation
Schizophrenia Patients

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014