A Clinical Trial to Investigate the Clinical Drug-Drug Interaction of Divarasib With Probe Substrates of P-Glycoprotein and Breast Cancer Resistance Protein in Healthy Participants

Cancer
Solid Tumors
Healthy Volunteers

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Basic Details

Sponsor Genentech, Inc.

Phase Phase 1

Study Identifier NCT06677957, GP45712

Condition Healthy Participants

Official Title A Phase I, Open-Label, Two-Period, One-Sequence, Crossover Study in Healthy Subjects to Evaluate the Clinical Drug-Drug Interaction of Divarasib With Probe Substrates of P-Glycoprotein (Digoxin) and Breast Cancer Resistance Protein (Rosuvastatin)

Study Summary

This is a Phase 1, open-label, two-period, one-sequence, crossover drug-drug interaction study to assess the P-gp and BCRP inhibition potential of divarasib using digoxin and rosuvastatin as probe substrates, respectively, 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 Clinical Trial to Investigate the Clinical Drug-Drug Interaction of Divarasib With Probe Substrates of P-Glycoprotein and Breast Cancer Resistance Protein 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 Clinical Trial to Investigate the Clinical Drug-Drug Interaction of Divarasib With Probe Substrates of P-Glycoprotein and Breast Cancer Resistance Protein in Healthy Participants

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