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HealthyPhase 1NCT01871987

Study to Evaluate the Effect of Food Intake on the Plasma Concentration Changes of Quetiapine After Oral Administration of FK949E in Healthy Volunteers

A Phase 1 study testing FK949E in people with Healthy and Plasma Concentration Change of Quetiapine, 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
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Trial summary

A study to evaluate the effect of food on the plasma concentration changes of quetiapine after oral administration of FK949E (extended release formulation of quetiapine) in healthy male subjects. Read more about this study

Who is it for?
Ages 20 to 44 years, men onlyHealthy volunteers can take part
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
24 participants
Where
1 siteJapan
Study dates
Jun 2009to Aug 2009
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 44 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Body weight : ≥50.0 kg, <85.0 kg
  • Body Mass Index : ≥17.6, <26.4
  • Healthy, as judged by the investigator/subinvestigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospital admission in Period 1 to immediately before study medication

Who cannot join

  • Subjects with the following history.
  • Hepatic disease (e.g. viral hepatitis, drug-induced liver injury).
  • Heart disease (e.g. congestive heart failure, angina pectoris, arrhythmia requiring
  • treatment).
  • Respiratory disease (e.g. serious bronchial asthma, chronic bronchitis)
  • Gastrointestinal disease (e.g. serious peptic ulcer, gastroesophageal reflux esophagitis;
Show all 32Show fewer
  • diseases requiring several selections except for appendicitis)
  • Renal disease (e.g. acute renal failure, glomerulonephritis, interstitial nephritis).
  • Cerebrovascular disorder (e.g. cerebral infarction).
  • Malignant tumor.
  • Drug allergies. Allergic disorders (except for hay fever)
  • Any use of drugs abuse. Alcohol abuse
  • Any concurrent illness (except for caries)
  • A deviation from the normal reference range of blood pressure, pulse rate, body temperature, or 12-lead ECG at screening or upon admission in Period 1 (day preceding the day of study medication).
  • Any deviation of the following criteria for clinical laboratory tests at screening or upon admission in Period 1 (day preceding the day of study medication). The normal reference ranges specified at the study site will be used as the normal reference ranges in the present study.
  • Hematology:
  • A deviation of ±20% from the upper or lower limit of the normal range
  • Blood biochemistry:
  • A deviation from the normal range for AST, ALT, creatinine (Cre), or serum electrolytes.
  • A deviation of ±20% from the upper or lower limit of the normal range for other items than the above.
  • However, the lower limit of the normal range will not be established for items for which a deviation from the lower limit is not considered clinically significant[AST, ALT, total bilirubin (T-Bil), ALP, γ-GTP, LDH, CK, Cre, uric acid (UA)and total cholesterol (T-Cho)].
  • Urinalysis:
  • U-Glu, U-Pro ≥+1
  • U-Uro ≥+2
  • Urinary drug test: A positive result for phencyclidine, benzodiazepine, cocaine, amphetamines, cannabis, opiates, barbiturates or tricyclic antidepressants
  • Immunological test: A positive result for HBs antigen, HCV antibody, syphilis, or HIV antigen/antibody
  • Received medication within 14 days before hospital admission in Period 1 or is scheduled to receive medication
  • Received any investigational drugs in other clinical or post-marketing studies within 120 days before the screening assessment
  • Previous treatment with FK949E
  • Donated more than 400 mL of whole blood within 90 days, more than 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment
  • Excessive smoking or drinking habit (measure of "excessive": alcohol: 45 g/day [a 633 mL bottle of beer contains 25 g of alcohol, and 180 mL of Japanese sake contains 22 g of alcohol], smoking: 20 cigarettes/day).
  • Other subjects concerned ineligible by the investigator/subinvestigator

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Study site

    Kyushu

Other trials in Japan

About this study

Official title: Pharmacokinetic Study of FK949E -A Pharmacokinetic Study in Healthy Male Volunteers to Investigate the Effect of Food on the Pharmacokinetics of FK949E

A study to evaluate the effect of food on the plasma concentration changes of quetiapine after oral administration of FK949E (extended release formulation of quetiapine) in healthy male subjects.

Read the detailed description

This is a 3-way cross-over study.

Being tested
FK949E
Keywords
FK949E, Quetiapine, Antipsychotic

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 NCT01871987
Study groupRoleWhat they receive
fasted groupExperimentalreceiving FK949E in fasted condition
Receives: Drug: FK949E
low fat groupExperimentalreceiving FK949E after low fat meal
Receives: Drug: FK949E
high fat groupExperimentalreceiving FK949E after high fat meal
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

    Measured: For 48 hours after dosing

  2. AUC (area under the curve) of unchanged quetiapine

    Measured: For 48 hours after dosing

Secondary outcomes (3)

  1. tmax of plasma concentration of unchanged quetiapine

    Measured: For 48 hours after dosing

  2. t1/2 of plasma concentration of unchanged quetiapine

    Measured: For 48 hours after dosing

  3. Safety assessed by the incidence of adverse events, clinical lab tests, vital signs, 12-lead ECGs and physical exam

    Measured: Up to 48 hours after each administration

Timeline

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

  1. First posted7 Jun 2013 (estimated)
  2. Study startJun 2009
  3. Primary completionAug 2009
  4. Study completionAug 2009

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
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01871987
Sponsor's protocol ID
6949-CL-0003
Status last verified
Mar 2017
First submitted
5 Jun 2013
Last updated
9 Mar 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FK949E in people with Healthy and Plasma Concentration Change of Quetiapine, 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 32 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 9 Mar 2017. 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 48 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 NCT01871987.

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 9 Mar 2017.

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