Comparison of Plasma Concentration Changes Between Two Types of Tablets of FK949E Administration to Patients With Major Depressive Disorder

Study Overview
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Brief Summary
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This study is to compare the pharmacokinetics of FK949E low dose tablets and FK949E high dose tablets in non-elderly patients with major depressive disorder. The safety of FK949E in the population was also evaluated.

Detailed Description
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The objective of the study is to compare the pharmacokinetics of FK949E low dose tablets and FK949E high dose tablets in non-elderly patients with major depressive disorder in a 2 × 2 crossover design. The safety of FK949E in the population is also evaluated.

Official Title
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Phase I Study of FK949E - Comparison of Pharmacokinetics Between FK949E 50 mg Tablets and FK949E 150 mg Tablets in Patients With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: FK949E


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients considered to be able to understand and follow subject requirements, as judged by the investigator/sub-investigator. Patients diagnosed with major depressive disorder according to the DSM-IV-TR by means of M.I.N.I. BMI: 17.6 (inclusive) to 26.4 (exclusive). Exclusion Criteria: Current or past history of DSM-IV-TR Axis I disorder, except major depressive disorder, within the past 6 months before informed consent. Concurrent DSM-IV-TR Axis II disorder that is considered to greatly affect patient's current mental status. Current or past history of dependence of substances (other than caffeine and nicotine) or history of abuse or dependence of alcohol. Unable to suspend treatment with inducers or inhibitors of the drug-metabolizing enzyme, cytochrome P450 3A4 (CYP3A4), for 14 days before the screening assessment and throughout the study. Patients who could not use an appropriate contraception (condoms) during the study. Patients who were pregnant or lactating. Patients (carriers) with documented or suspected renal failure, hepatic failure, serious cardiac disease, hepatitis B, hepatitis C, or acquired immunodeficiency syndrome (AIDS). Patients receiving treatment for hypertension, or patients with concurrent hypertension or unstable angina that may worsen with the study or may affect the study results based on the clinical judgment of the investigator/sub-investigator. Patients with concurrent hypotension (criterion for hypotension: a systolic blood pressure of less than 100 mmHg), or orthostatic hypotension Patients with a mean QTcF interval of ≥450 ms on a 12-lead ECG at the screening assessment Patients with the risk of torsades de pointe (e.g., those with a history of QT prolongation, those with familial long QT syndrome). Concurrent malabsorption syndrome, hepatic disease, or other conditions that may affect the absorption and/or metabolism of the study drug. Concurrent malignancy or history of cured malignancy within 5 years Current or past history of cerebrovascular disease or transient ischemic attack (TIA). Received electroconvulsive therapy within 90 days before the screening assessment

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (FK949E low dose tablet-first group)<br>Days 1 and 2: One FK949E low dose tablet Days 3 to 6: Three FK949E low dose tablets Days 7 to 10: One FK949E high dose tablet | Drug: FK949E<br>* Oral<br>* Other names: extended release formulation of quetiapine;|
| Experimental: Group 2 (FK949E high dose tablet-first group)<br>Days 1 and 2: One FK949E low dose tablet Days 3 to 6: One FK949E high dose tablet Days 7 to 10: Three FK949E low dose tablets | Drug: FK949E<br>* Oral<br>* Other names: extended release formulation of quetiapine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) of unchanged quetiapine | Frequent blood sampling on Day 6 and Day 10 | For 24 hours after dosing | 
| AUC24h (area under the curve for 24hr) of unchanged quetiapine | Frequent blood sampling on Day 6 and Day 10 | For 24 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough value of plasma concentration of unchanged quetiapine | Frequent blood sampling on Day 6 and Day 10 | For 24 hours after dosing | 
| t1/2 of plasma concentration of unchanged quetiapine | Frequent blood sampling on Day 6 and Day 10 | For 24 hours after dosing | 
| Maximum plasma concentration (Cmax) of quetiapine metabolites | Frequent blood sampling on Day 6 and Day 10 | For 24 hours after dosing | 
| AUC (area under the curve) of quetiapine metabolites | Frequent blood sampling on Day 6 and Day 10 | For 24 hours after dosing | 
| trough value of plasma concentration of quetiapine metabolites | Frequent blood sampling on Day 6 and Day 10 | For 24 hours after dosing | 
| tmax of plasma concentration of quetiapine metabolites | Frequent blood sampling on Day 6 and Day 10 | For 24 hours after dosing | 
| t1/2 of plasma concentration of quetiapine metabolites | Frequent blood sampling on Day 6 and Day 10 | For 24 hours after dosing | 
| Safety assessed by the incidence of adverse events, clinical tab tests, vital signs, 12-lead ECGs and physical exam |  | Up to Day 11 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FK949E, Pharmacokinetics, Major Depressive Disorder