Comparison of Plasma Concentration Changes Between Two Types of Tablets of FK949E Administration to Patients With Major Depressive Disorder
Phase 1
Completed
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: FK949E
- Registration Number
- NCT01919008
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group 2 (FK949E high dose tablet-first group) FK949E 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 Group 1 (FK949E low dose tablet-first group) FK949E 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
- Primary Outcome Measures
Name Time Method Maximum plasma concentration (Cmax) of unchanged quetiapine For 24 hours after dosing Frequent blood sampling on Day 6 and Day 10
AUC24h (area under the curve for 24hr) of unchanged quetiapine For 24 hours after dosing Frequent blood sampling on Day 6 and Day 10
- Secondary Outcome Measures
Name Time Method Trough value of plasma concentration of unchanged quetiapine For 24 hours after dosing Frequent blood sampling on Day 6 and Day 10
t1/2 of plasma concentration of unchanged quetiapine For 24 hours after dosing Frequent blood sampling on Day 6 and Day 10
Maximum plasma concentration (Cmax) of quetiapine metabolites For 24 hours after dosing Frequent blood sampling on Day 6 and Day 10
AUC (area under the curve) of quetiapine metabolites For 24 hours after dosing Frequent blood sampling on Day 6 and Day 10
trough value of plasma concentration of quetiapine metabolites For 24 hours after dosing Frequent blood sampling on Day 6 and Day 10
tmax of plasma concentration of quetiapine metabolites For 24 hours after dosing Frequent blood sampling on Day 6 and Day 10
t1/2 of plasma concentration of quetiapine metabolites For 24 hours after dosing Frequent blood sampling on Day 6 and Day 10
Safety assessed by the incidence of adverse events, clinical tab tests, vital signs, 12-lead ECGs and physical exam Up to Day 11