NCT05199610

An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of EQ143

An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of EQ143 in Participants With Severe Hepatic Impairment and in Matched Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: EQRx International, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Participants aged 18 to 75 years with severe hepatic impairment (Child-Pugh class C) who meet the full study eligibility criteria will be enrolled into the study. For each participant with severe hepatic impairment, a corresponding healthy participant will be enrolled who matches with regard to age, sex, and BMI. A single dose of 55-mg EQ143 tablet will be administered in the morning on Day 1, and participants will remain for 5 days (4 nights) in the study center for collection of blood samples and safety monitoring. Participants will attend outpatient follow-up visits on Days 5, 6, 8, and 9 for additional blood sampling and safety assessments. The study will measure and describe the concentrations of EQ143 and its metabolite (HAS-719) in plasma over the course of 9 days (including calculation of PK parameters), the degree of EQ143 and metabolite HAS-719 (and other metabolites, if applicable) binding to proteins in plasma, and the safety of administering a single dose of EQ143 in severely hepatically impaired and matched healthy participants

Conditions

• Severe Hepatic Impairment

Interventions

Type	Name	Description
DRUG	aumolertinib	A single dose of 55-mg EQ143 tablet will be administered in the morning on Day 1, and participants will remain for 5 days (4 nights) in the study center for collection of blood samples and safety monitoring. Participants will attend outpatient follow-up visits on Days 5, 6, 8, and 9 for additional blood sampling and safety assessments.

Timeline

• Start date: 2022-03-30
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2022-01-20
• Last updated: 2023-04-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study