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OpenTrials
Completed

NCT Number: NCT06734208

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

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami, Inc., Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Divarasib

Drug

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

Primary outcomes

  1. Plasma Concentration of Divarasib

    Time frame: Day 1 to Day 7

  2. Maximum Observed Concentration (Cmax) of Divarasib

    Time frame: Day 1 to Day 7

  3. Area Under the Concentration-time Curve from Hour 0 to the last measurable concentration (AUC0-t) of Divarasib

    Time frame: Day 1 to Day 7

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

    Time frame: Day 1 to Day 7

Secondary outcomes

  1. Percentage of Participants With Adverse Events (AEs)

    Time frame: Up to Week 10

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2024
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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