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Liver function and drug processing: a closer look at divarasib

NCT ID NCT06734208

Knowledge-focused Sponsor: Genentech, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how the drug divarasib is processed in the bodies of 31 people with different levels of liver function, from healthy to severely impaired. Participants received a single dose, and researchers measured drug levels in the blood over time. The goal was to understand how liver health affects drug clearance, not to treat any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

31 people

The number who actually took part.

Started

Jan 2025

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

liver disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatic impairment

Contacts and locations

Locations

  • American Research Corporation Inc.

    San Antonio, Texas, 78215, United States

  • Clinical Pharmacology of Miami, Inc.

    Miami, Florida, 33014, United States

  • Orlando Clinical Research Center

    Orlando, Florida, 32809, United States

  • Panax Clinical Research, LLC

    Miami Lakes, Florida, 33014, United States

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