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

NCT01919008 | Completed Phase 1

• 1 other identifier: 6949-CL-0006
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

FK949E; Pharmacokinetics; Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• Maximum plasma concentration (Cmax) of unchanged quetiapine

  Frequent blood sampling on Day 6 and Day 10

  For 24 hours after dosing

• 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 Outcomes (8)

• Trough value of plasma concentration of unchanged quetiapine

  For 24 hours after dosing

• t1/2 of plasma concentration of unchanged quetiapine

  For 24 hours after dosing

• Maximum plasma concentration (Cmax) of quetiapine metabolites

  For 24 hours after dosing

• AUC (area under the curve) of quetiapine metabolites

  For 24 hours after dosing

• trough value of plasma concentration of quetiapine metabolites

  For 24 hours after dosing

Study Arms (2)

Group 1 (FK949E low dose tablet-first group)

EXPERIMENTAL

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

Drug: FK949E

Group 2 (FK949E high dose tablet-first group)

EXPERIMENTAL

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

Drug: FK949E

Interventions

FK949E DRUG

Oral

Also known as: extended release formulation of quetiapine

Group 1 (FK949E low dose tablet-first group); Group 2 (FK949E high dose tablet-first group)

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Kanto, Japan

Location

Related Publications (1)

• 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.

  PMID: 32792252 DERIVED

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 8, 2013
• Study Start: March 26, 2012
• Primary Completion: June 22, 2012
• Study Completion: June 22, 2012
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)