Study to Evaluate the Pharmacokinetics (PK) of E7090 (Herein Referred to as Tasurgratinib) and Its Metabolite in Participants With Mild and Moderate Hepatic Impairment Compared to Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-27

Study Completion Date

2026-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary purpose of the study is to evaluate the effects of mild and moderate hepatic impairment on PK of tasurgratinib after a single dose administration.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib

NCT07144111

Hepatic Impairment

RECRUITING PHASE1

A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hepatic Function

NCT05674474

Hepatic Impairment

COMPLETED PHASE1

Single-Dose PK and Safety Study of GBT440 in Subjects With Hepatic Impairment

NCT03114540

Hepatic Impairment

COMPLETED PHASE1

A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants

NCT03341884

Hepatic Insufficiency

COMPLETED PHASE1

Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.

NCT02624557

Hepatic Impairment

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatic Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort A: Mild Hepatic Impairment (Child Pugh Class A)

Participants with mild hepatic impairment will receive a single 35 milligram (mg) tablet of tasurgratinib in the morning with 150 milliliters (mL) of water following an overnight fast of at least 10 hours.

Group Type EXPERIMENTAL

Tasurgratinib

Intervention Type DRUG

Tasurgratinib oral tablet.

Cohort B: Moderate Hepatic Impairment (Child Pugh Class B)

Participants with moderate hepatic impairment will receive 10 mg dose of tasurgratinib as capsule (2 capsules each of 5 mg) in the morning with 150 mL of water following an overnight fast of at least 10 hours.

Group Type EXPERIMENTAL

Tasurgratinib

Intervention Type DRUG

Tasurgratinib oral capsule.

Cohort C: Healthy Participants (Control)

Healthy participants matched to participants with hepatic impairment in Cohorts A and B (matched with regards to age, race, gender and body weight) will receive a single 35 mg tablet of tasurgratinib in the morning with 150 mL of water following an overnight fast of at least 10 hours.

Group Type EXPERIMENTAL

Tasurgratinib

Intervention Type DRUG

Tasurgratinib oral tablet.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tasurgratinib

Tasurgratinib oral tablet.

Intervention Type DRUG

Tasurgratinib

Tasurgratinib oral capsule.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Body mass index (BMI) between 18 to 40 kilogram per square meter (kg/m\^2).
2. For Cohorts A and B: stable hepatic impairment conforming to Child-Pugh classification A and B.
3. For Cohort C: healthy participants matched to participants with hepatic impairment with regard to age (+/-10 years), body weight (+/-20 percent \[%\]), race and gender, and as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations.

Exclusion Criteria

Key Exclusion for all Participants:

1. Following ocular disorders

1. Current evidence of Grade 2 or higher corneal disorder
2. Current evidence of active macular disorder (example, Age-related macular degeneration, central serous chorioretinal disease)
2. Known to be human immunodeficiency virus (HIV) positive at Screening.
3. A prolonged QT/QTc interval (\[QT interval using Fridericia's formula\] QTcF greater than (\>) 480 millisecond \[ms\]) demonstrated on ECG.

1. Any significant acute medical illness (such as new conditions or exacerbation of pre-existing conditions) within 8 weeks of dosing.
2. Presence of severe ascites, edema, or uncontrolled hepatic encephalopathy
3. The participant's standard therapy/concomitant medication for diseases related to hepatic disease has not remained stable/unchanged for at least two weeks before dosing of study drug.

1. Syphilis as demonstrated by positive serology at Screening.
2. Any abnormal finding based on physical examination, assessment of vital signs, ECG, or laboratory test results that requires treatment or clinical follow up based on investigators opinion.

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes