- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01919008
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
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
-
-
-
Kanto, Japan
-
-
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:
|
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:
|
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.
Sponsor
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
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Depression
- Depressive Disorder
- Disease
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Quetiapine Fumarate
Other Study ID Numbers
- 6949-CL-0006
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.
Clinical Trials on Major Depressive Disorder
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on FK949E
-
Astellas Pharma IncCompleted
-
Astellas Pharma IncCompleted
-
Astellas Pharma IncCompleted
-
Astellas Pharma IncCompleted
-
Astellas Pharma IncCompletedMajor Depressive DisorderJapan
-
Astellas Pharma IncCompletedHealthy | Plasma Concentration Change of QuetiapineJapan
-
Astellas Pharma IncCompletedMajor Depressive Disorder PatientsJapan
-
Astellas Pharma IncCompletedMajor Depressive Disorder PatientsJapan
-
Astellas Pharma IncCompletedHealthy | Pharmacokinetics of QuetiapineJapan