A Performance and Bioavailability Study of Entrectinib in Healthy Volunteers.
NCT03961100 2019-000783-15 GP41341
The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.
The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.
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.
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
- A body mass index (BMI) between 18.0 and 32.0 kilogram per square meter (kg/m2), inclusive, and weighing >/=50 kg.
- Agreement to comply with measures to prevent pregnancy and restrictions on egg and sperm donation
- Women of childbearing potential, women who are pregnant or breastfeeding, or intending to become pregnant during the study or within 14 days after the final dose of entrectinib or have a pregnant partner
- A clinical significant medical history of gastrointestinal surgery (e.g., gastric bypass) or other gastrointestinal disorder (e.g., malabsorption syndrome) that might affect absorption of medicines from the gastrointestinal tract
- Presence of a clinically significant disease, illness, medical condition or disorder, or any other medical history determined by the investigator to be clinically significant and relevant
- Clinically significant change in health status, or any major illness, or clinically significant acute infection or febrile illness
- Use of moderate or potent inhibitors or inducers of CYP P450 3A4 enzyme or P-gp transporter, or use of other prohibited medications
- Participation in any other clinical study involving an investigational medicinal product (IMP) or device
- A positive test result for hepatitis B, hepatitis C (HCV), or human immunodeficiency virus (HIV)
- Current smokers and those who have smoked, or users of e-cigarettes and nicotine replacement products within the last 12 months
- Known history of clinically significant hypersensitivity, or severe allergic reaction, to entrectinib or related compounds
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