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

July 22, 2019 updated by: Astellas Pharma Inc

Phase I Study of FK949E - Comparison of Pharmacokinetics Between FK949E 50 mg Tablets and FK949E 150 mg Tablets in Patients With Major Depressive Disorder

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.

Study Overview

Status

Completed

Intervention / Treatment

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

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

Oral
Other Names:
  • 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

Oral
Other Names:
  • extended release formulation of quetiapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration (Cmax) of unchanged quetiapine
Time Frame: For 24 hours after dosing
Frequent blood sampling on Day 6 and Day 10
For 24 hours after dosing
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
For 24 hours after dosing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough value of plasma concentration of unchanged quetiapine
Time Frame: For 24 hours after dosing
Frequent blood sampling on Day 6 and Day 10
For 24 hours after dosing
t1/2 of plasma concentration of unchanged quetiapine
Time Frame: For 24 hours after dosing
Frequent blood sampling on Day 6 and Day 10
For 24 hours after dosing
Maximum plasma concentration (Cmax) of quetiapine metabolites
Time Frame: For 24 hours after dosing
Frequent blood sampling on Day 6 and Day 10
For 24 hours after dosing
AUC (area under the curve) of quetiapine metabolites
Time Frame: For 24 hours after dosing
Frequent blood sampling on Day 6 and Day 10
For 24 hours after dosing
trough value of plasma concentration of quetiapine metabolites
Time Frame: For 24 hours after dosing
Frequent blood sampling on Day 6 and Day 10
For 24 hours after dosing
tmax of plasma concentration of quetiapine metabolites
Time Frame: For 24 hours after dosing
Frequent blood sampling on Day 6 and Day 10
For 24 hours after dosing
t1/2 of plasma concentration of quetiapine metabolites
Time Frame: For 24 hours after dosing
Frequent blood sampling on Day 6 and Day 10
For 24 hours after dosing
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
Up to Day 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2012

Primary Completion (Actual)

June 22, 2012

Study Completion (Actual)

June 22, 2012

Study Registration Dates

First Submitted

August 6, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (Estimate)

August 8, 2013

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 22, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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