This study aims to demonstrate similarities between two different forms of entrectinib (A and C) when administered under fasted conditions in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Participants will receive a single oral dose of entrectinib form A under fasted conditions.
Participants will receive a single oral dose of entrectinib form C under fasted conditions.
Covance Research Unit - Dallas
Dallas, Texas, United States
Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite
Time frame: At pre-defined intervals from Hour 0 through Day 5 of each study Period (Periods 1 and 2 = 6 days)
Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite
Time frame: At pre-defined intervals from Hour 0 through Day 5 of each study Period (Periods 1 and 2 = 6 days)
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: Baseline through the end of study (up to clinical cut-off date 06 Feb 2019 [28 days])
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