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HealthyPhase 1NCT01908296

Study to Evaluate the Effect of Multiple-dose of Fluvoxamine on the Plasma Concentration of Quetiapine (FK949E) in Healthy Male Volunteers

A Phase 1 study testing FK949E and fluvoxamine in people with Healthy and Pharmacokinetics 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

The objective of the study was to assess the effect of multiple-dose fluvoxamine on the pharmacokinetics of quetiapine (FK949E) in healthy adult male subjects. The safety of FK949E in the population was also evaluated. Read more about this study

Who is it for?
Ages 20 to 44 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy, Pharmacokinetics of Quetiapine
What is being tested?
FK949E and fluvoxamine
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
Jul 2011to Aug 2011
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, <80.0 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 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;
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  • 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)
  • Drug dependence, alcohol dependence
  • Any disease (except dental caries)
  • A deviation from the normal reference range of blood pressure, pulse rate, body temperature, or 12-lead ECG
  • A deviation of the following criteria for clinical laboratory tests.
  • 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), HbA1c 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), BUN, and total cholesterol (T-Cho)].
  • Urinalysis:
  • U-Glc and/or U-Pro results of (±) or worse
  • U-Uro results of (+) or worse
  • Urinary drug test:
  • A positive result for phencyclidine, benzodiazepine, cocaine, amphetamines, cannabis, opiates, barbiturates or tricyclic antidepressants
  • Immunological test:
  • A positive result for hepatitis B, hepatitis C, syphilis, or HIV
  • History of treatment, including medication, within 14 days before the start of study drug administration
  • Consumption of food or beverages containing St. John's Wort within 14 days before the start of study drug administration, or consumption of grapefruit
  • Previous participation in a pre- or post-marketing clinical study of another prescription drug or a medical device within 120 days before the study
  • History of administration of quetiapine
  • History of administration of fluvoxamine
  • Whole blood sampling of 400 mL or more within 90 days before the screening assessment, whole blood sampling of 200 mL or more within 30 days before the screening assessment, or blood component donation within 14 days before the screening assessment
  • Routine excessive alcohol consumption ("excessive alcohol" is defined as an average of 45 g of alcohol per day [cf., a large bottle of beer containing 25 g of alcohol, 180 mL of sake containing 22 g of alcohol])
  • Subjects with a smoking habit (except those who quit smoking at least 90 days before the screening assessment)

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Study site

    Kyushu

Other trials in Japan

About this study

Official title: Phase I Study of FK949E - A Study of Drug-drug Interactions Between FK949E and Fluvoxamine in Healthy Male Adults

The objective of the study was to assess the effect of multiple-dose fluvoxamine on the pharmacokinetics of quetiapine (FK949E) in healthy adult male subjects. The safety of FK949E in the population was also evaluated.

Being tested
FK949E, fluvoxamine
Keywords
FK949E, fluvoxamine, Antipsychotic, Quetiapine

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

  • fluvoxamineDrug

    Also called Luvox®

    Oral

Study groups in NCT01908296
Study groupRoleWhat they receive
FK949E groupExperimentalreceiving FK949E with and without fluvoxamine
Receives: Drug: FK949E; Drug: fluvoxamine

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 (11)

  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. Maximum plasma concentration (Cmax) of quetiapine metabolites

    Measured: For 48 hours after dosing.

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

    Measured: For 48 hours after dosing.

  5. tmax of plasma concentration of quetiapine metabolites

    Measured: For 48 hours after dosing.

  6. t1/2 of plasma concentration of quetiapine metabolites

    Measured: For 48 hours after dosing.

  7. Maximum plasma concentration (Cmax) of unchanged fluvoxamine

    Measured: For 12 hours after dosing.

  8. AUC (area under the curve) of unchanged fluvoxamine

    Measured: For 12 hours after dosing.

  9. tmax of plasma concentration of unchanged fluvoxamine

    Measured: For 12 hours after dosing.

  10. t1/2 of plasma concentration of unchanged fluvoxamine

    Measured: For 12 hours after dosing.

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

    Measured: Up to 20 Days.

Timeline

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

  1. First posted25 Jul 2013 (estimated)
  2. Study startJul 2011
  3. Primary completionAug 2011
  4. Study completionAug 2011

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01908296
Sponsor's protocol ID
6949-CL-0004
Status last verified
Feb 2017
First submitted
23 Jul 2013
Last updated
16 Feb 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FK949E and fluvoxamine in people with Healthy and Pharmacokinetics 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 37 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 16 Feb 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 NCT01908296.

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 16 Feb 2017.

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