A Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Divarasib in Healthy Participants

Genentech, Inc.18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

DivarasibDRUG

Divarasib will be administered as a single oral dose as specified for the respective period.

ItraconazoleDRUG

Itraconazole will be administered BID on Day 1 and QD from Day 2 to 13 and as specified for the respective period.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Males or females of non-childbearing potential * Within body mass index (BMI) range of 18.0 to 32.0 kg/m2, inclusive Exclusion Criteria: * 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

Locations (1)

Dallas Clinical Research Unit

Dallas, Texas, United States

Outcomes

Primary Outcomes

Maximum Plasma Concentration (Cmax) of Divarasib

Time frame: Day 1 of Period 1 and Day 5 of Period 2

Area Under the Concentration-time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Divarasib

Time frame: Day 1 of Period 1 and Day 5 of Period 2

Area Under the Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Divarasib

Time frame: Day 1 of Period 1 and Day 5 of Period 2

Secondary Outcomes

Percentage of Participants With Adverse Events (AEs)

Time frame: Up to Week 12

Data from ClinicalTrials.gov

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