The Bioequivalence Of Two Different Lurasidone Formulations In Patients

NCT01082250 | Completed Phase 1 DMC

• 1 other identifier: D1050263
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Keywords

Bioequivalence; Male/Female Patient; Reference/Test Formulation; Schizophrenia Patients

Study Arms (2)

Reference Formulation

OTHER

Dosed 12.5% drugload 3X40mg

Drug: Lurasidone HCl

Test Formulation

OTHER

25% Drugload 1X120mg

Drug: Lurasidone HCl

Interventions

Lurasidone HCl DRUG

120mg dose. 3-way cross-over for 21 days

Reference Formulation; Test Formulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Body mass index (BMI) ≥ 19.5 and ≤ 37 kg/m2.
• No clinically relevant abnormal laboratory values.
• No clinically significant findings in the 12-lead electrocardiogram (ECG):
• No clinically significant findings from a vital signs measurement.
• Able to understand and provide written consent prior to initiating any study procedure after being informed of the nature of the study.
• 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.
• 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.

You may not qualify if:

• 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.
• Known history or presence of intolerance to psychiatric medications (e.g. atypical antipsychotic medications).
• History of alcohol or drug-dependence as per DSM-IV criteria during the 6-month period immediately prior to study entry.
• 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).
• 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.
• A history of epilepsy or risk of having seizures.
• Positive test results within 30 days prior to the start of the study for:
• Human immunodeficiency virus (HIV).
• Hepatitis B surface antigen and Hepatitis C antibody.
• Urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
• Serum beta-HCG consistent with pregnancy (females only).
• Participated in another clinical trial or received an investigational product within 30 days prior to Screening.
• 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.
• Difficulty fasting or consuming the standard meals.
• Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (1)

California Clinical Trials (CCT)

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Lev Gertsik, MD

  California Clinical Trials (CCT)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 8, 2010
• Study Start: July 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 8, 2011

Record last verified: 2011-09

Locations

US (1)