Clinical trial NCT01919008: Comparison of Plasma Concentration Changes Between Two Types of Tablets of FK949E Administration to Patients With Major Depressive Disorder
Official title: Phase I Study of FK949E - Comparison of Pharmacokinetics Between FK949E 50 mg Tablets and FK949E 150 mg Tablets in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depressive Disorder
Keywords: FK949E
Pharmacokinetics
Major Depressive Disorder
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-08-08
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of unchanged quetiapine
timeFrame: For 24 hours after dosing
measure: AUC24h (area under the curve for 24hr) of unchanged quetiapine
timeFrame: For 24 hours after dosing
Secondary outcomes:
measure: Trough value of plasma concentration of unchanged quetiapine
timeFrame: For 24 hours after dosing
measure: t1/2 of plasma concentration of unchanged quetiapine
timeFrame: For 24 hours after dosing
measure: Maximum plasma concentration (Cmax) of quetiapine metabolites
timeFrame: For 24 hours after dosing
measure: AUC (area under the curve) of quetiapine metabolites
timeFrame: For 24 hours after dosing
measure: trough value of plasma concentration of quetiapine metabolites
timeFrame: For 24 hours after dosing
measure: tmax of plasma concentration of quetiapine metabolites
timeFrame: For 24 hours after dosing
measure: t1/2 of plasma concentration of quetiapine metabolites
timeFrame: For 24 hours after dosing
measure: Safety assessed by the incidence of adverse events, clinical tab tests, vital signs, 12-lead ECGs and physical exam
timeFrame: Up to Day 11
Other outcomes:
Locations:
city: Kanto
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Fukushi R, Nomura Y, Katashima M, Komatsu K, Sato Y, Takada A. Approach to Evaluating QT Prolongation of Quetiapine Fumarate in Late Stage of Clinical Development Using Concentration-QTc Modeling and Simulation in Japanese Patients With Bipolar Disorder. Clin Ther. 2020 Aug;42(8):1483-1493.e1. doi: 10.1016/j.clinthera.2020.06.002. Epub 2020 Aug 11.