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Healthy VolunteerPhase 1NCT03964038

A Study to Assess the Relative Bioavailability of Gilteritinib Following a Single Dose of Gilteritinib Mini-tablet Oral Suspension and Gilteritinib Mini-tablets Compared to a Single Dose of Gilteritinib Tablet in Healthy Subjects

A Phase 1 study testing gilteritinib and gilteritinib mini tablet in people with Healthy Volunteer, run by Astellas Pharma Global Development, Inc. at 1 site in United States.

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 purpose of this study is to assess the relative bioavailability as well as the safety and tolerability of single doses of gilteritinib mini-tablets oral suspension and gilteritinib mini tablets compared to gilteritinib tablets under fasting conditions in healthy male and female participants. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
gilteritinib and gilteritinib mini tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
21 May 2019to 16 Jul 2019
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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subject has a body mass index range of 18.5 to 32.0 kg/m2, inclusive and weighs at least 50 kg at screening.
  • Female subject is not pregnant and the following condition applies:
  • Subject is not a woman of childbearing potential.
  • Male subject with female partner(s) of childbearing potential (including breastfeeding partner[s]) must agree to use contraception throughout the treatment period and for 120 days after study treatment administration.
  • Male subject must not donate sperm during the treatment period and for 120 days after study treatment administration.
  • Male subject with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 120 days after study treatment administration.
  • Subject agrees not to participate in another interventional study while participating in the present study.

Who cannot join

  • Subject has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
  • Subject has any condition which makes the subject unsuitable for study participation.
  • Female subject who has been pregnant within 6 months prior to screening assessment or breastfeeding within 3 months prior to screening.
  • Subject has a known or suspected hypersensitivity to gilteritinib, or any components of the formulations used.
  • Subject has had previous exposure with gilteritinib.
  • Subject has any of the liver function tests (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase and total bilirubin) ≥ 1.5 × upper limit of normal on day -1. In such a case, the assessment may be repeated once.
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  • Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to study treatment administration.
  • Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy.
  • Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week prior to day -1.
  • Subject has any clinically significant abnormality following the investigator's review of the physical examination, electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or on day -1.
  • Subject has a mean pulse < 45 or > 90 bpm; mean systolic blood pressure > 140 mmHg; mean diastolic blood pressure > 90 mmHg (measurements taken in triplicate after subject has been resting in the supine position for at least 5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
  • Subject has a mean corrected QT interval using Fridericia's formula (QTcF) interval of > 430 msec (for male subjects) and > 450 msec (for female subjects) on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG may be taken.
  • Subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease or a family history of long QT syndrome.
  • Subject has used any prescribed or nonprescribed drugs (including vitamins and natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to study treatment administration, except for occasional use of paracetamol (up to 2 g/day), topical dermatological products, including corticosteroid products and hormone replacement therapy (HRT).
  • Subject has smoked, used tobacco-containing products and nicotine or nicotine-containing products (e.g., electronic vapes) within 6 months prior to screening.
  • Subject has a history of consuming > 14 units for male subjects or 7 units for female subjects of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within 2 years prior to screening (note: 1 unit = 12 ounces of beer, 4 ounces of wine, 1 ounce of spirits/hard liquor) or the subject tests positive for alcohol at screening or on day -1.
  • Subject has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) within 3 months prior to day -1 or the subject tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) at screening or on day -1.
  • Subject has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 3 months prior to day -1.
  • Subject has had significant blood loss, donated ≥ 1 unit (450 mL) of whole blood or donated plasma within 7 days prior to day -1 and/or received a transfusion of any blood or blood products within 60 days.
  • Subject has a positive serology test for hepatitis A virus antibodies (immunoglobulin M), hepatitis B core, hepatitis B surface antigen, hepatitis C virus antibodies or antibodies to human immunodeficiency virus type 1 and/or type 2 at screening.
  • Subject is an employee of Astellas, the study-related contract research organizations or the clinical unit.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • EPCU - Parexel

    Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: A Phase 1 Parallel Study to Assess the Relative Bioavailability of Gilteritinib Following a Single Dose of Gilteritinib Mini-tablet Oral Suspension and Gilteritinib Mini-tablets Compared to a Single Dose of Gilteritinib Tablet in Healthy Subjects

The purpose of this study is to assess the relative bioavailability as well as the safety and tolerability of single doses of gilteritinib mini-tablets oral suspension and gilteritinib mini tablets compared to gilteritinib tablets under fasting conditions in healthy male and female participants.

Read the detailed description

Participants will be screened for up to 28 days prior to investigational product (IP) administration on day 1. Eligible participants will be admitted to the clinical unit on day -1 and will be residential for 10 days/9 nights.

Being tested
gilteritinib, gilteritinib mini tablet
Keywords
gilteritinib, ASP2215, Healthy volunteer

What participants receive

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

  • gilteritinibDrug

    Also called ASP2215

    oral

  • gilteritinib mini tabletDrug

    Also called ASP2215

    oral

Study groups in NCT03964038
Study groupRoleWhat they receive
gilteritinibActive comparatorParticipants will receive a single dose of gilteritinib under fasting conditions.
Receives: Drug: gilteritinib
gilteritinib mini-tablet oral suspensionExperimentalParticipants will receive a single dose of gilteritinib oral suspension with water under fasting conditions.
Receives: Drug: gilteritinib mini tablet
gilteritinib mini-tabletExperimentalParticipants will receive a single dose of gilteritinib mini-tablets under fasting conditions.
Receives: Drug: gilteritinib mini tablet

What is being measured

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

  1. Pharmacokinetics (PK) of gilteritinib in plasma: area under the concentration-time curve from the time of dosing to 72 hours (AUC72)

    AUC72 will be recorded from the PK plasma samples collected.

    Measured: Up to Day 9

  2. Pharmacokinetics (PK) of gilteritinib in plasma: area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf)

    AUCinf will be recorded from the PK plasma samples collected.

    Measured: Up to Day 9

  3. Pharmacokinetics (PK) of gilteritinib in plasma: area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)

    AUClast will be recorded from the PK plasma samples collected.

    Measured: Up to Day 9

  4. Pharmacokinetics (PK) of gilteritinib in plasma: maximum concentration (Cmax)

    Cmax will be recorded from the PK plasma samples collected.

    Measured: Up to Day 9

Secondary outcomes (4)

  1. Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)

    Adverse Events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered an investigational product (IP) and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP.

    Measured: Up to Day 18

  2. Number of participants with laboratory value abnormalities and/or adverse events (AEs)

    Number of participants with potentially clinically significant laboratory values.

    Measured: Up to Day 18

  3. Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)

    Number of participants with potentially clinically significant ECG values.

    Measured: Up to Day 18

  4. Number of participants with vital sign abnormalities and /or adverse events (AEs)

    Number of participants with potentially clinically significant vital sign values.

    Measured: Up to Day 18

Timeline

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

  1. First posted28 May 2019
  2. Study start21 May 2019
  3. Primary completion2 Jul 2019
  4. Study completion16 Jul 2019

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03964038
Sponsor's protocol ID
2215-CL-0602
Status last verified
Jun 2020
First submitted
20 May 2019
Last updated
16 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
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/.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing gilteritinib and gilteritinib mini tablet in people with Healthy Volunteer, run by Astellas Pharma Global Development, Inc. at 1 site in United States.

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 7 inclusion and 21 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 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 United States. 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?

Pharmacokinetics (PK) of gilteritinib in plasma: area under the concentration-time curve from the time of dosing to 72 hours (AUC72) (time frame: Up to Day 9). The study lists 4 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 NCT03964038.

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 Oct 2024.

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