NCT04969965

To Evaluate the Comparative Pharmacokinetics of Orally Administered EQ143 in Different Racial and Ethnic Populations

A Single Dose Phase 1 Study in Healthy Participants to Evaluate the Comparative Pharmacokinetics of Orally Administered EQ143 in Different Racial and Ethnic Populations

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: EQRx, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is an open-label and uncontrolled study to evaluate the comparative PK of EQ143 following oral single dose administration in adult healthy volunteers different racial and ethnic populations. A total of one (1) single dose cohort is planned at 110 mg of EQ143. EQ143 is an approved therapy in China at the 110 mg dose for the treatment of patients with Epidermal Growth Factor Receptor (EGFR) T790Mmutation-positive, metastatic non-small cell lung cancer (NSCLC), who have progressed during or after EGFR tyrosine kinase inhibitor (TKI) therapy. A total of 45 (15 Caucasian, 8 Black/African American and 7 Hispanic/Latino, and 15 ethnic Chinese)

Conditions

• NSCLC
• Healthy Volunteers
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	aumolertinib	EQ143 tablet is an oral solid dosage form manufactured at a strength of 55 mg

Timeline

• Start date: 2021-06-21
• Primary completion: 2021-10-07
• Completion: 2021-10-07
• First posted: 2021-07-21
• Last updated: 2022-06-28

Locations

2 sites across 2 countries: United States, New Zealand

Regulatory

• FDA-regulated drug study