Covance Research Unit - Daytona
Daytona Beach, Florida, 32117, United States
NCT Number: NCT03796260
This study aims to investigate the relative bioavailability, safety, and tolerability of entrectinib capsule formulations F1 and F06 under fed conditions in healthy adult male and female participants.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Daytona Beach, Florida, 32117, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a single oral dose of entrectinib F1 after completion of a standardized meal.
Participants will receive a single oral dose of entrectinib F06 after completion of a standardized meal.
Time frame: At pre-defined intervals from study Day 1 through Day 5 of each Period (Periods 1 and 2 = 6 days)
The area under the concentration-time curve extrapolated to infinity is calculated using the formula: AUC0-inf = AUC0-t + (Ct/λz) where Ct is the last measurable concentration and λz is the apparent terminal elimination rate constant. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern.
Time frame: At pre-defined intervals from study Day 1 through Day 5 of each Period (Periods 1 and 2 = 6 days)
The area under the concentration-time curve calculated from Hour 0 to the last measurable concentration, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern.
Time frame: At pre-defined intervals from study Day 1 through Day 5 of each Period (Periods 1 and 2 = 6 days)
The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern.
Time frame: Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days])
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.
Genentech, Inc.
Industry
A Randomized, Open-Label, Two-Treatment, Two-Period, Two-Way Crossover Study to Investigate the Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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