To Evaluate the Comparative Pharmacokinetics of Orally Administered EQ143 in Different Racial and Ethnic Populations
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|ClinicalTrials.gov Identifier: NCT04969965|
Recruitment Status : Completed
First Posted : July 21, 2021
Last Update Posted : November 9, 2021
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)
|Condition or disease||Intervention/treatment||Phase|
|NSCLC Healthy Volunteers Pharmacokinetics||Drug: aumolertinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Dose Phase 1 Study in Healthy Participants to Evaluate the Comparative Pharmacokinetics of Orally Administered EQ143 in Different Racial and Ethnic Populations|
|Actual Study Start Date :||June 21, 2021|
|Actual Primary Completion Date :||October 7, 2021|
|Actual Study Completion Date :||October 7, 2021|
single dose oral 110mg of aumolertinib
EQ143 tablet is an oral solid dosage form manufactured at a strength of 55 mg. Each EQ143 tablet contains EQ143 drug substance, microcrystalline cellulose (KG802), anhydrous lactose (21AN), sodium carboxymethyl starch (type A), sodium stearyl fumarate and magnesium stearate (MF-2-V). EQ143 is orally administered once at a dose of 110 mg (two tablets) for each single dose.
Other Name: EQ143
- To compare the concentration (called PK) of EQ143 in the blood following a single oral administration in adult, healthy participants. [ Time Frame: Pharmacokinetic (PK) blood sampling will be conducted at pre-dose (within 1 hour prior to dosing) on day 1at an interval of 1 and 2 hours and Day 2, Day 3, Day 4, Day 5, Day 6, and Day 8 post-dose and at the end of study (EOS) visit (10 days post-dose). ]
- To evaluate the safety and tolerability of EQ143 following a single oral administration in adult, healthy, Caucasian, Black or African American, Hispanic or Latino, and ethnic Chinese populations. [ Time Frame: 12-38 Days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04969965
|United States, Wisconsin|
|Spaulding Clinical Research|
|West Bend, Wisconsin, United States, 53095|
|New Zealand Clinical Research|
|Auckland, New Zealand|