A Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Divarasib in Healthy Participants
- Healthy Volunteers
Not yet recruiting
- United States
NCT06690138 GP45714
Trial Summary
This is a Phase 1, open-label, two-period, fixed sequence drug-drug interaction study to evaluate the impact of multiple doses of Itraconazole on the pharmacokinetics (PK) and safety of Divarasib in healthy participants.
A Phase 1, Open-Label, Single-Dose, Two-Period, Fixed Sequence, Crossover Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Divarasib in Healthy Subjects
Eligibility Criteria
- Males or females of non-childbearing potential
- Within body mass index (BMI) range of 18.0 to 32.0 kg/m2, inclusive
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
- Poor peripheral venous access
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