Healthy participants Not Applicable
Conditions
Interventions
Participants will be randomized according to a randomization schedule generated by a Fortrea biostatistician.
Treatment A, followed by treatment B: Participants will first receive divarasib, 400 mg
Sponsors
Genentech
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetic (PK) parameters of divarasib measured using blood samples collected over 5 days on periods 1 and 2. The following PK parameters will be calculated if data allows: 1.1.Maximum observed concentration (Cmax) of divarasib measured using plasma concentration of divarasib collected over 5 days on period 1 and 2 1.2. Area under the concentration-time curve extrapolated to infinity (AUC 0-8) of divarasib measured using plasma concentration of divarasib collected over 5 days on period 1 and 2 1.3. Area under the concentration-time curve from hour 0 to last measurable concentration (AUC 0-t) of divarasib measured using plasma concentration of divarasib collected over 5 days on period 1 and 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of participants with adverse events (AEs) graded as per national cancer institute common terminology criteria for adverse events version 5.0 (NCI CTCAE; v5.0) from signing of informed consent up to Day 28 of Period 2 (approximately 5 weeks) | — |
Countries
United States of America
Contacts
Public ContactClinical Trials
Outcome results
None listed