A study to compare how much of divarasib is absorbed after a single oral dose of two different tablet formulations in healthy participants

Phase 1

• Conditions: Healthy participants; Not Applicable

• Registration Number: ISRCTN16486589
• Lead Sponsor: Genentech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-28
• Last Update Posted: 29 April 2024
• Study Completion: 2024-05-08

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Males or females of non-childbearing potential
2. Body mass index (BMI) ranges from 18.0 to 32.0 kilogram per meter square (kg/m^2)
3. In good health, determined by no clinically significant findings from medical history, physical examination, triplicate 12-lead electro cardiogram (ECGs), and vital signs
4. Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check-in (Day -1 of Period 1) (does include alcohol)
5. Negative hepatitis panel (hepatitis B surface antigen, hepatitis B virus core antibody, and hepatitis C virus antibody) and negative Human Immunodeficiency Virus (HIV) antibody screens
6. Able to comply with the study protocol, including an overnight (at least 8 hours) fast before dosing

Exclusion Criteria

1. Significant history or clinical manifestation of any metabolic, allergic (to any drug compound, food, or other substance), dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI) (stomach or intestinal surgery or resection), neurological, or psychiatric disorder
2. History of significant hypersensitivity, significant intolerance, or significant allergy to any drug compound, food, or other substance, unless approved by the investigator
3. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer, before Check-in (Period 1 Day -1)
4. Receipt of a coronavirus disease 2019 (COVID-19) vaccine in the past 28 days before Check-in (Period 1 Day -1)
5. Use of any prescription medications/products within 14 days prior to Check-in (Period 1 Day -1), unless deemed acceptable by the investigator
6. Serious infection requiring oral antibiotics within 4 weeks or intravenous (IV) antibiotics within 8 weeks of Screening
7. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy and hernia repair will be allowed

Study & Design

• Study Type: Interventional
• Study Design: Not specified