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

NCT06734208 | Completed Phase 1 FDA Drug

• 1 other identifier: GP45713
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 4

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.

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Percentage of Participants With Adverse Events (AEs)

  Up to Week 10

Study Arms (4)

Cohort 1

EXPERIMENTAL

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

Drug: Divarasib

Cohort 2

EXPERIMENTAL

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

Drug: Divarasib

Cohort 3

EXPERIMENTAL

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

Drug: Divarasib

Cohort 4

EXPERIMENTAL

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

Drug: Divarasib

Interventions

Divarasib DRUG

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

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (4)

Clinical Pharmacology of Miami, Inc.

Miami, Florida, 33014, United States

Location

Panax Clinical Research, LLC

Miami Lakes, Florida, 33014, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

American Research Corporation Inc.

San Antonio, Texas, 78215, United States

Location

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: January 31, 2025
• Primary Completion: November 27, 2025
• Study Completion: November 27, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)