Major Depressive Disorder
Conditions
Keywords
FK949E, Pharmacokinetics, Major Depressive Disorder
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.
Interventions
DRUGFK949E
Oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 | — |
| 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 unchanged quetiapine | For 24 hours after dosing | Frequent blood sampling on Day 6 and Day 10 |
Countries
Japan
Outcome results
None listed