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

Genentech

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Divarasib; Drug: Rifampin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06835465

GP45718

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 60 years old

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Treatment A

Experimental group

Description:

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

Treatment:

Drug: Divarasib

Treatment B

Experimental group

Description:

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.

Treatment:

Drug: Rifampin

Drug: Divarasib