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

A Phase 1, Open-Label, Single-Dose, Two-Period, Fixed Sequence, Crossover Study to Determine the Effect of Rifampin on the Pharmacokinetics of Divarasib in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06835465

Enrollment

Registered

2025-02-19

Start date

2025-02-21

Completion date

2025-05-06

Last updated

2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

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.

Interventions

DRUGDivarasib

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

DRUGRifampin

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 design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Percentage of Participants With Adverse Events (AEs)	Up to Week 14

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026