Skip to main content
OpenTrials
Completed

NCT Number: NCT06690138

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Participants

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dallas Clinical Research Unit

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Divarasib

Drug

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

Itraconazole

Drug

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

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of Divarasib

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

  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

  3. 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

  1. Percentage of Participants With Adverse Events (AEs)

    Time frame: Up to Week 12

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 15, 2024
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.