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

NCT06690138 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-04-15

No results posted yet for this study

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.

Conditions

  • Healthy Participants

Interventions

DRUG

Divarasib

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

DRUG

Itraconazole

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

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2025-02-11
Completion
2025-02-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06690138 on ClinicalTrials.gov