A Performance and Bioavailability Study of Entrectinib in Healthy Volunteers.

• Status: Completed
• Trial end date: 2019-08-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Entrectinib

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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