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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose and 1, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 192 hours post dose
Awards & highlights
Study Summary
This trial will study the effects of a new drug, EQ143, on people with severe liver impairment. For each person with severe liver impairment enrolled, a corresponding healthy person will be enrolled as well. EQ143 will be given as a single dose, and participants will remain in the study center for 5 days for blood sampling and safety monitoring. There will be follow-up visits on Days 5, 6, 8, and 9 for additional blood sampling and safety assessments.
Eligible Conditions
- Liver Damage
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose and 1, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 192 hours post dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose and 1, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 192 hours post dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PK Parameter: AUC0-t of EQ143
PK Parameter: AUC0-t of metabolite, HAS719
PK Parameter: AUCinf of EQ143
+4 moreSecondary outcome measures
Number of Participants with Adverse Event
PK Parameter of EQ143: Time to peak concentration (tmax)
PK Parameter of EQ143: apparent volume of distribution (Vz/F)
+12 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: AumolertinibExperimental Treatment1 Intervention
single dose oral 55mg of aumolertinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
aumolertinib
2021
Completed Phase 1
~60
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
EQRx, Inc.Lead Sponsor
3 Previous Clinical Trials
145 Total Patients Enrolled
EQRx International, Inc.Lead Sponsor
3 Previous Clinical Trials
8 Total Patients Enrolled
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