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Itraconazole and Divarasib Interaction Study

Phase 1

Recruiting

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Within body mass index (BMI) range of 18.0 to 32.0 kg/m2, inclusive

Males or females of non-childbearing potential

Must not have

Poor peripheral venous access

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing how taking multiple doses of itraconazole affects how Divarasib works in the body and if it is safe to do so in healthy participants."

Who is the study for?

This trial is for healthy individuals who can participate in a study to understand how Itraconazole affects the body's handling of another drug, Divarasib. Specific eligibility criteria are not provided.

What is being tested?

The study is testing how taking Itraconazole, an antifungal medication, influences the levels and effects of Divarasib, a potential new treatment being tested in healthy participants over two different periods.

What are the potential side effects?

Since specific side effects are not listed for this trial, generally Itraconazole may cause nausea, headache or stomach pain while Divarasib as a new drug could have unknown side effects that will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My BMI is between 18.0 and 32.0.

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I cannot become pregnant or get someone pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have difficulty with blood draws or IV insertions due to poor vein access.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment BExperimental Treatment2 Interventions

Participants will receive Itraconazole twice a day (BID) on Day 1 and once a day (QD) from Day 2 to Day 13. Participants will receive Divarasib in combination with Itraconazole on Day 5.

Group II: Treatment AExperimental Treatment1 Intervention

Participants will receive a single oral dose of Divarasib on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Divarasib

2021

Completed Phase 1

~430

Itraconazole

2017