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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Genentech, Inc.
Study ID
NCT06690138
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Nov 15, 2024
Status verified
Apr 2025
Primary completion
Feb 11, 2025
Completion
Feb 11, 2025

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Treatment A
    Participants will receive a single oral dose of Divarasib on Day 1.
  • Experimental: Treatment B
    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.

Primary Outcome Measure

Maximum Plasma Concentration (Cmax) of Divarasib [ Time Frame: Day 1 of Period 1 and Day 5 of Period 2 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dallas Clinical Research UnitDallasTexas75247-

Find similar trials in Dallas, TX

By research site
Dallas Clinical Research Unit· Dallas, TX

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