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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
oral
oral
EPCU - Parexel
Baltimore, Maryland, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Day 9
Pharmacokinetics (PK) of gilteritinib in plasma: maximum concentration (Cmax)
Cmax will be recorded from the PK plasma samples collected.
Time frame: Up to Day 9
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.
Time frame: Up to Day 18
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to Day 18
Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant ECG values.
Time frame: Up to Day 18
Number of participants with vital sign abnormalities and /or adverse events (AEs)
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to Day 18
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