Quotient Clinical Ltd, Clinical Research Unit
Nottingham, NG11 6JS, United Kingdom
NCT Number: NCT03961100
This study will evaluate the bioavailability, palatability, safety and tolerability of entrectinib in healthy volunteers. Part 1 of the study will explore the performance of entrectinib multi-particle formulation. Part 2 will evaluate the effect of drug substance particle size on entrectinib bioavailability.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Nottingham, NG11 6JS, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Test formulation 1 (T1): Multi-particulate formulation 1: entrectinib film-coated mini-tablets
Test formulation 2 (T2): Multi-particulate formulation 2: entrectinib film-coated mini-tablets
Reference formulation (R): entrectinib hard capsules
Test formulation (T): entrectinib HPMC capsules
Time frame: At pre-defined intervals from study Day 1 to Day 5 of each periods (each period=7 days)
Time frame: At pre-defined intervals from study Day 1 to Day 5 of each periods (each period=7 days)
Time frame: At pre-defined intervals from study Day 1 to Day 5 of each periods (each period=7 days)
Time frame: At pre-defined intervals from study Day 1 to Day 5 of each periods (each period=7 days)
Time frame: From Day -1 to Day 5 of each periods (each period=7 days)
An adverse event (AE) 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. Treatment-emergent adverse events (TEAEs) are AEs that were not present before the first dose of study drug or that were present before the first dose of study drug but worsened in intensity during exposure to study drug.
Genentech, Inc.
Industry
A Randomized, Open-Label, Two Part Study to Explore the Performance of Entrectinib Prototype Mini-Tablet Formulations and the Effect of Drug Substance Particle Size On Entrectinib Bioavailability in Healthy Volunteers
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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