A Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Divarasib in Healthy Participants

Part of paid clinical trials in Dallas, Texas.

Sponsor
Genentech, Inc.
Study ID
NCT06835465
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.
  • Rifampin — DRUG
    Rifampin will be administered QD on Days 1 to 7 and Days 9 to 13 and as a single oral dose on Day 8 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 rifampin on the pharmacokinetics (PK) and safety of divarasib in healthy participants.

Key Dates

Start date
Feb 21, 2025
Status verified
May 2025
Primary completion
May 6, 2025
Completion
May 6, 2025

Study Design

Enrollment
18 participants (actual)
Allocation
NON_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 Rifampin once daily (QD) on Days 1 to 7 and Days 9 to 13. Participants will receive Divarasib followed by Rifampin on Day 8.

Primary Outcome Measure

Maximum Plasma Concentration (Cmax) of Divarasib [ Time Frame: Day 1 of Period 1 and Day 8 of Period 2 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fortrea Dallas CRUDallasTexas75247-

Find similar trials in Dallas, TX

By research site
Fortrea Dallas CRU· Dallas, TX

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