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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01919008
• Other study ID #: 6949-CL-0006
• Status: Completed
• Phase: Phase 1
• Start date: March 26, 2012
• Est. completion date: June 22, 2012

Study information

• Verified date: July 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 22, 2012
• Est. primary completion date: June 22, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• FK949E
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

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

External Links

•   Link to results on Astellas Clinical Study Results website