A study to assess the distribution of entrectinib capsule in the blood of healthy adults compared to nasogastric and oral suspension of entrectinib

Phase 1

• Conditions: Bioavailability of entrectinib in healthy participants; Not Applicable

• Registration Number: ISRCTN57815030
• Lead Sponsor: F. Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-03
• Last Update Posted: 22 August 2022
• Study Completion: 2022-10-17

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Female of non-childbearing potential or male, between 18 and 55 years of age, inclusive, at Screening
2. Within body mass index (BMI) range of 18.0 to 32.0 kg/m², inclusive, and weighing at least 50 kg at Screening
3. Healthy in the opinion of the investigator. Healthy is defined by the absence of evidence of any active disease or clinically significant medical condition based on a detailed medical history, physical examination, vital signs and 12-lead ECG assessment, and clinical laboratory evaluation results
4. Negative hepatitis panel (hepatitis B surface antigen and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) antibody screens
5. Females must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at each Check-in (Day -1)

Exclusion Criteria

1. Women of childbearing potential, women who are pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of entrectinib
2. Males who have a pregnant partner
3. A clinically significant medical history of gastrointestinal (GI) surgery (e.g., gastric bypass) or other GI disorder (e.g., malabsorption syndrome) that might affect absorption of medicines from the GI tract.
4. Clinically significant lactose intolerance
5. 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. Ongoing chronic disorders which are not considered clinically significant are permissible provided they are stable
6. A clinically significant abnormal physical examination finding
7. Use of moderate or potent inhibitors or inducers of CYP3A4 enzyme or P-glycoprotein (P-gp) transporter within 28 days or 5 half-lives, whichever is longer, before Period 1 dosing (Day 1). Additionally, for subjects enrolled in Part 2, use of moderate or potent inhibitors or inducers of CYP2C19 within 28 days or 5 half-lives, whichever is longer, before Period 1 dosing (Day 1)
8. Use of gastric pH-modifying agents such as protein pump inhibitor (PPIs), H2 receptor antagonists, and antacids, within 28 days or 5 half-lives, whichever is longer, before Period 1 dosing (Day 1)
9. Administration of a Coronavirus Disease 2019 vaccine in the past 7 days prior to Period 1 dosing (Day 1)
10. Participation in any other clinical study involving an investigational medicinal product (IMP) or device within 60 days or 5 half-lives (if known), whichever is longer, prior to Period 1 dosing (Day 1)
11. Known history of clinically significant hypersensitivity, or severe allergic reaction, to entrectinib or related compounds (Part 1 and Part 2) or lansoprazole or related compounds (Part 2 only)
12. Previous enrollment in this study. Subjects who have taken part in Part 1 are not permitted to take part in Part 2

Study & Design

• Study Type: Interventional
• Study Design: Not specified