Study to Evaluate Safety and Tolerability of FK949E in Patients With Major Depressive Disorder

NCT01871974 | Completed Phase 1

• 1 other identifier: 6949-CL-0001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of the study was to evaluate the safety and plasma concentration changes of quetiapine after multiple oral administration of FK949E (extended-release formulation of quetiapine) in patients with major depressive disorder (MDD).

Conditions

Major Depressive Disorder Patients

Keywords

FK949E; Antipsychotic; Quetiapine

Outcome Measures

Primary Outcomes (1)

• Maximum plasma concentration (Cmax) of unchanged quetiapine

  For 24 hours after dosing

Secondary Outcomes (4)

• AUC (area under the curve) of unchanged quetiapine

  For 24 hours after dosing

• tmax of plasma concentration of unchanged quetiapine

  For 24 hours after dosing

• t1/2 of plasma concentration of unchanged quetiapine

  For 24 hours after dosing

• Safety assessed by the incidence of adverse events, clinical lab tests, vital signs, 12-lead ECGs and physical exam

  Up to 21 days

Study Arms (2)

low-dose group FK949E

EXPERIMENTAL

oral

Drug: FK949E

high-dose group FK949E

EXPERIMENTAL

oral

Drug: FK949E

Interventions

FK949E DRUG

oral

Also known as: extended release formulation of quetiapine

high-dose group FK949E; low-dose group FK949E

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of major depressive disorder according to the DSM-IV-TR (Text Revision of the Diagnostic and Statistical Manual of Mental Disorders version-4)
• Female patients of childbearing potential with a negative serum pregnancy test result and who were willing and able to use a reliable method of birth control during the study
• Patients who could understand and comply with the requirements of the study, as judged by the investigator/sub-investigator

You may not qualify if:

• A current or past history of a DSM-IV-TR Axis I disorder other than major depressive disorder within 6 months prior to the study
• Diagnosis of a DSM-IV-TR Axis II disorder that was considered to have a major impact on the patient's current psychiatric status
• A history of substance or alcohol abuse or dependence excluding caffeine and nicotine
• Patients who were unable to abstain from drugs that induce or inhibit the drug-metabolizing enzyme CYP3A4 from 14 days prior to the start of study drug administration and throughout the study period
• Pregnant or lactating women
• Patients showing evidence or signs of renal or hepatic failure, serious heart disease, cerebrovascular disease, viral hepatitis B or C, or acquired immunodeficiency syndrome (AIDS) (carrier)
• A clinical finding that in the opinion of the investigator/sub-investigator could be negatively affected by the study or that would affect the study results (e.g., hypertension, unstable angina)
• Conditions that could affect absorption and metabolism of the study medication (e.g., malabsorption syndrome, liver disease)
• A current diagnosis of malignant tumor unless in remission for at least 5 years (except basal or squamous cell skin carcinoma)
• A current or past diagnosis of transient ischemic attack (TIA)
• A history of seizure disorder, except for febrile convulsions
• Application of electroconvulsive therapy within 90 days prior to the start of study drug administration
• Use of a depot antipsychotic injection and inability to be off the drug for a period of twice the dosing interval prior to the start of study drug administration and throughout the study period
• Patients could require psychotherapy (other than supportive psychotherapy) during the study period, unless psychotherapy had been ongoing for a minimum of 90 days prior to the start of study drug administration
• A score of ≥ 3 on the HAM-D17 Item (suicide) or a suicide attempt within the past 6 months, and those judged to be at serious suicidal or homicidal risk in the opinion of the investigator/sub-investigator

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (2)

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Related Links

• Link to results on Astellas Clinical Study Results website

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 7, 2013
• Study Start: May 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

JP (2)