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

NCT03964038 | Completed Phase 1 FDA Drug

• 1 other identifier: 2215-CL-0602
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Keywords

gilteritinib; ASP2215; Healthy volunteer

Outcome Measures

Primary Outcomes (4)

• 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.

  Up to Day 9

• 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.

  Up to Day 9

• 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.

  Up to Day 9

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

  Cmax will be recorded from the PK plasma samples collected.

  Up to Day 9

Secondary Outcomes (4)

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

  Up to Day 18

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

  Up to Day 18

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

  Up to Day 18

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

  Up to Day 18

Study Arms (3)

gilteritinib

ACTIVE COMPARATOR

Participants will receive a single dose of gilteritinib under fasting conditions.

Drug: gilteritinib

gilteritinib mini-tablet oral suspension

EXPERIMENTAL

Participants will receive a single dose of gilteritinib oral suspension with water under fasting conditions.

Drug: gilteritinib mini tablet

gilteritinib mini-tablet

EXPERIMENTAL

Participants will receive a single dose of gilteritinib mini-tablets under fasting conditions.

Drug: gilteritinib mini tablet

Interventions

gilteritinib DRUG

oral

Also known as: ASP2215

gilteritinib

gilteritinib mini tablet DRUG

oral

Also known as: ASP2215

gilteritinib mini-tablet; gilteritinib mini-tablet oral suspension

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (1)

EPCU - Parexel

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

gilteritinib

Study Officials

• Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 28, 2019
• Study Start: May 21, 2019
• Primary Completion: July 2, 2019
• Study Completion: July 16, 2019
• Last Updated: October 16, 2024

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)