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CompletedNCT01919008Updated Oct 31, 2024

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

A Phase 1 interventional study of FK949E in Major Depressive Disorder, sponsored by Astellas Pharma Inc. Completed at 1 site in Japan. Open to participants aged 20 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-10-31.

Sponsored by Astellas Pharma Inc · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Mar 2012, registered Aug 2013).
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
20 Years to 64 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • FK949E
  • Pharmacokinetics
  • Major Depressive Disorder
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 16 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugFK949E

    Oral

    Also known as: extended release formulation of quetiapine

06

What researchers measure

Primary outcomes

  1. Maximum plasma concentration (Cmax) of unchanged quetiapine

    Frequent blood sampling on Day 6 and Day 10

    Time frame: For 24 hours after dosing

  2. AUC24h (area under the curve for 24hr) of unchanged quetiapine

    Frequent blood sampling on Day 6 and Day 10

    Time frame: For 24 hours after dosing

Secondary outcomes

  1. Trough value of plasma concentration of unchanged quetiapine

    Frequent blood sampling on Day 6 and Day 10

    Time frame: For 24 hours after dosing

  2. t1/2 of plasma concentration of unchanged quetiapine

    Frequent blood sampling on Day 6 and Day 10

    Time frame: For 24 hours after dosing

  3. Maximum plasma concentration (Cmax) of quetiapine metabolites

    Frequent blood sampling on Day 6 and Day 10

    Time frame: For 24 hours after dosing

  4. AUC (area under the curve) of quetiapine metabolites

    Frequent blood sampling on Day 6 and Day 10

    Time frame: For 24 hours after dosing

  5. trough value of plasma concentration of quetiapine metabolites

    Frequent blood sampling on Day 6 and Day 10

    Time frame: For 24 hours after dosing

  6. tmax of plasma concentration of quetiapine metabolites

    Frequent blood sampling on Day 6 and Day 10

    Time frame: For 24 hours after dosing

  7. t1/2 of plasma concentration of quetiapine metabolites

    Frequent blood sampling on Day 6 and Day 10

    Time frame: For 24 hours after dosing

  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

07

Study locations

1 site
  • Kanto, Japan
08

References and documents

Publications

  • 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. PubMed 32792252 ↗

Individual participant data

Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01919008
Lead sponsor
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Aug 8, 2013
Start date
Mar 26, 2012
Primary completion
Jun 22, 2012
Completion
Jun 22, 2012
Last update
Oct 31, 2024

Study contacts

Medical Director
study director · Astellas Pharma Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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