Clinical trial NCT01082250: The Bioequivalence Of Two Different Lurasidone Formulations In Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Bioequivalence
Male/Female Patient
Reference/Test Formulation
Schizophrenia Patients
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-08
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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

Detailed description: 12.5% Drugload 3X40mg vs. 25% Drugload 1X120mg

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: California Clinical Trials (CCT)
state: California
Study officials:
affiliation: California Clinical Trials (CCT)
name: Lev Gertsik, MD
role: PRINCIPAL_INVESTIGATOR
References: