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Trial record 18 of 854 for:    tablet | Japan

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

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ClinicalTrials.gov Identifier: NCT01919008
Recruitment Status : Completed
First Posted : August 8, 2013
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: FK949E Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 Start Date : March 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 (FK949E low dose tablet-first group)

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
Oral
Other Name: extended release formulation of quetiapine

Experimental: Group 2 (FK949E high dose tablet-first group)

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
Oral
Other Name: extended release formulation of quetiapine




Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) of unchanged quetiapine [ Time Frame: For 24 hours after dosing ]
    Frequent blood sampling on Day 6 and Day 10

  2. AUC24h (area under the curve for 24hr) of unchanged quetiapine [ Time Frame: For 24 hours after dosing ]
    Frequent blood sampling on Day 6 and Day 10


Secondary Outcome Measures :
  1. Trough value of plasma concentration of unchanged quetiapine [ Time Frame: For 24 hours after dosing ]
    Frequent blood sampling on Day 6 and Day 10

  2. t1/2 of plasma concentration of unchanged quetiapine [ Time Frame: For 24 hours after dosing ]
    Frequent blood sampling on Day 6 and Day 10

  3. Maximum plasma concentration (Cmax) of quetiapine metabolites [ Time Frame: For 24 hours after dosing ]
    Frequent blood sampling on Day 6 and Day 10

  4. AUC (area under the curve) of quetiapine metabolites [ Time Frame: For 24 hours after dosing ]
    Frequent blood sampling on Day 6 and Day 10

  5. trough value of plasma concentration of quetiapine metabolites [ Time Frame: For 24 hours after dosing ]
    Frequent blood sampling on Day 6 and Day 10

  6. tmax of plasma concentration of quetiapine metabolites [ Time Frame: For 24 hours after dosing ]
    Frequent blood sampling on Day 6 and Day 10

  7. t1/2 of plasma concentration of quetiapine metabolites [ Time Frame: For 24 hours after dosing ]
    Frequent blood sampling on Day 6 and Day 10

  8. Safety assessed by the incidence of adverse events, clinical tab tests, vital signs, 12-lead ECGs and physical exam [ Time Frame: Up to Day 11 ]


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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01919008


Locations
Japan
Kanto, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Inc

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01919008     History of Changes
Other Study ID Numbers: 6949-CL-0006
First Posted: August 8, 2013    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017

Keywords provided by Astellas Pharma Inc:
FK949E
Pharmacokinetics
Major Depressive Disorder

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms