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

Healthy Volunteers

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Basic Details

Sponsor Genentech, Inc.

Phase Phase 1

Study Identifier NCT06690138, GP45714

Condition Healthy Participants

Official Title 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

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.

Eligibility Criteria

Gender

All

Age

≥18 Years & ≤ 60 Years

Healthy Volunteers

Accepts Healthy Volunteers

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

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

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

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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

For the latest version of this information please go to www.forpatients.roche.com