A Study to Evaluate the Pharmacokinetics of Divarasib in Healthy Participants and Participants With Impaired Hepatic Function

A Phase 1, Open-Label, Single-Dose, Parallel-Cohort Study to Evaluate the Pharmacokinetics of Divarasib in Subjects With Impaired Hepatic Function

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06734208

Enrollment

Registered

2024-12-16

Start date

2025-01-31

Completion date

2025-11-27

Last updated

2025-12-04

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

Conditions

Hepatic Impairment

Brief summary

This is a phase 1, open-label, single-dose, parallel-cohort study to determine the pharmacokinetics (PK) of divarasib in healthy participants and participants with varying degrees of hepatic impairment, as defined by Child-Pugh classification.

Interventions

DRUGDivarasib

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria * Males or females of non-childbearing potential * Within body mass index (BMI) range of 18.0 to 45.0 kg/m2 Participants with Hepatic Impairment * Considered to have mild, moderate, or severe hepatic impairment by Child-Pugh Score classification and has been clinically stable for at least 1 month prior to Screening * Chronic (\>6 months), stable hepatic insufficiency with features of cirrhosis due to any etiology. Participants must also remain stable throughout the Screening period Key

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 Participants with Hepatic Impairment * Have a QTcF \>480 msec for males and \>490 msec for females at Screening or Check-in. If any parameter is out of range, the ECG may be repeated for confirmation * Any evidence of progressive liver disease that has worsened or is worsening, as determined by the investigator, within 1 month prior to Screening * Demonstrated evidence of hepatorenal syndrome * Ascites requiring paracentesis or other intervention up to 3 days prior to the study * Hepatic encephalopathy Grade 2 or above

Design outcomes

Primary

Measure	Time frame
Plasma Concentration of Divarasib	Day 1 to Day 7
Maximum Observed Concentration (Cmax) of Divarasib	Day 1 to Day 7
Area Under the Concentration-time Curve from Hour 0 to the last measurable concentration (AUC0-t) of Divarasib	Day 1 to Day 7
Area Under the Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Divarasib	Day 1 to Day 7

Secondary

Measure	Time frame
Percentage of Participants With Adverse Events (AEs)	Up to Week 10

Countries

United States

Outcome results

None listed

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