The Bioequivalence Of Two Different Lurasidone Formulations In Patients

Completed · Phase 1

Conditions studied: Schizophrenia

In brief

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

Key facts

Study ID

NCT01082250

Run by

Sumitomo Pharma America, Inc.

People needed

52

Starts

2008-07-01

Expected to finish

2008-09-01

Last updated by the study team

2011-09-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.
• OR- Females having used implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing.
• Donation or loss of whole blood prior to drug administration, as follows:
• ≤ 499 mL within 30 days prior to dosing
• ≥ 500 mL within 56 days prior to dosing.
• Patient has a prolactin concentration ≥ 100 ng/mL at Screening.

Where it is running

• California Clinical Trials (CCT) — Glendale, California, United States

Full record on ClinicalTrials.gov

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