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

NCT06835465 | Completed Phase 1 FDA Drug

• 1 other identifier: GP45718
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax) of Divarasib

  Day 1 of Period 1 and Day 8 of Period 2

• Area Under the Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Divarasib

  Day 1 of Period 1 and Day 8 of Period 2

• Area Under the Concentration-time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Divarasib

  Day 1 of Period 1 and Day 8 of Period 2

Secondary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs)

  Up to Week 14

Study Arms (2)

Treatment A

EXPERIMENTAL

Participants will receive a single oral dose of Divarasib on Day 1.

Drug: Divarasib

Treatment B

EXPERIMENTAL

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.

Drug: Divarasib; Drug: Rifampin

Interventions

Divarasib DRUG

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

Treatment A; Treatment B

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.

Treatment B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females of non-childbearing potential
• Within body mass index (BMI) range of 18.0 to 32.0 kg/m2, inclusive

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Fortrea Dallas CRU

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

Rifampin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: February 21, 2025
• Primary Completion: May 6, 2025
• Study Completion: May 6, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)