AzTrials
AzTrials

Major Depressive DisorderPhase 1NCT01919008

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

A Phase 1 study testing FK949E in people with Major Depressive Disorder, run by Astellas Pharma Inc at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 20 to 64 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
FK949E
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteJapan
Study dates
26 Mar 2012to 22 Jun 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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,
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Study site

    Kanto

Other trials in Japan

About this study

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

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.

Being tested
FK949E
Keywords
FK949E, Pharmacokinetics, Major Depressive Disorder
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FK949EDrug

    Also called extended release formulation of quetiapine

    Oral

Study groups in NCT01919008
Study groupRoleWhat they receive
Group 1 (FK949E low dose tablet-first group)ExperimentalDays 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
Receives: Drug: FK949E
Group 2 (FK949E high dose tablet-first group)ExperimentalDays 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
Receives: Drug: FK949E

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum plasma concentration (Cmax) of unchanged quetiapine

    Frequent blood sampling on Day 6 and Day 10

    Measured: 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

    Measured: For 24 hours after dosing

Secondary outcomes (8)

  1. Trough value of plasma concentration of unchanged quetiapine

    Frequent blood sampling on Day 6 and Day 10

    Measured: For 24 hours after dosing

  2. t1/2 of plasma concentration of unchanged quetiapine

    Frequent blood sampling on Day 6 and Day 10

    Measured: For 24 hours after dosing

  3. Maximum plasma concentration (Cmax) of quetiapine metabolites

    Frequent blood sampling on Day 6 and Day 10

    Measured: For 24 hours after dosing

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

    Frequent blood sampling on Day 6 and Day 10

    Measured: For 24 hours after dosing

  5. trough value of plasma concentration of quetiapine metabolites

    Frequent blood sampling on Day 6 and Day 10

    Measured: For 24 hours after dosing

  6. tmax of plasma concentration of quetiapine metabolites

    Frequent blood sampling on Day 6 and Day 10

    Measured: For 24 hours after dosing

  7. t1/2 of plasma concentration of quetiapine metabolites

    Frequent blood sampling on Day 6 and Day 10

    Measured: 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

    Measured: Up to Day 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2013 (estimated)
  2. Study start26 Mar 2012
  3. Primary completion22 Jun 2012
  4. Study completion22 Jun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01919008
Sponsor's protocol ID
6949-CL-0006
Status last verified
Oct 2024
First submitted
6 Aug 2013
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
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/.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FK949E in people with Major Depressive Disorder, run by Astellas Pharma Inc at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum plasma concentration (Cmax) of unchanged quetiapine (time frame: For 24 hours after dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01919008, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in