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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age20-79
SponsorEisai Co., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body mass index (BMI) between 18 to 40 kilogram per square meter (kg/m²).

For Cohorts A and B: stable hepatic impairment conforming to Child-Pugh classification A and B.

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.

Disqualifiers

Following ocular disorders

Current evidence of Grade 2 or higher corneal disorder

Current evidence of active macular disorder (example, Age-related macular degeneration, central serous chorioretinal disease)

Known to be human immunodeficiency virus (HIV) positive at Screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tasurgratinib

    Drug

    Tasurgratinib oral tablet.

  • Tasurgratinib

    Drug

    Tasurgratinib oral capsule.

Treatment groups

18 Participants
are divided into 3 treatment groups
Group A: Cohort A: Mild Hepatic Impairment (Child Pugh Class A)Experimental treatment 1 intervention
Group B: Cohort B: Moderate Hepatic Impairment (Child Pugh Class B)Experimental treatment 1 intervention
Group C: Cohort C: Healthy Participants (Control)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cmax: Maximum Observed Plasma Concentration of Tasurgratinib

Time frame
Day 1: 0-144 hours postdose
2

AUC(0-t): Area Under the Plasma Concentration versus Time Curve from Time 0 to Time of Last Quantifiable Concentration of Tasurgratinib

Time frame
Day 1: 0-144 hours postdose
3

AUC(0-inf): Area Under the Plasma Concentration versus Time Curve from Time 0 to Infinity of Tasurgratinib

Time frame
Day 1: 0-144 hours postdose

Secondary outcomes

1

Tmax: Time to Reach Maximum Plasma Concentration of Tasurgratinib and its Metabolite

Time frame
Day 1: 0-144 hours postdose
2

AUC(0-72Hours): Area Under the Plasma Concentration versus Time Curve from Time 0 to 72 Hours of Tasurgratinib and its Metabolite

Time frame
Day 1: 0-144 hours postdose
3

T1/2: Terminal Phase Plasma Half-life of Tasurgratinib and its Metabolite

Time frame
Day 1: 0-144 hours postdose
4

CL/F: Apparent Total Body Clearance of Tasurgratinib

Time frame
Day 1: 0-144 hours postdose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.