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

NCT04969965 | Completed Phase 1 FDA Drug

• 1 other identifier: EQ143-101
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• To compare the concentration (called PK) of EQ143 in the blood following a single oral administration in adult, healthy participants.

  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).

Secondary Outcomes (1)

• 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.

  12-38 Days

Study Arms (1)

Aumolertinib

EXPERIMENTAL

single dose oral 110mg of aumolertinib

Drug: aumolertinib

Interventions

aumolertinib DRUG

EQ143 tablet is an oral solid dosage form manufactured at a strength of 55 mg

Also known as: EQ143

Aumolertinib

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant self-reports as being of one of the following racial or ethnic groups:
• being of non-Chinese, European descent
• having origins in any of the black racial groups of Africa
• being of Cuban, Mexican, Puerto Rican, Cuban, South or Central American, or other Spanish culture or origin, regardless of race
• having two Han Chinese biological parents;
• Is capable of giving informed consent and complying with study procedures;
• Healthy male or female participants, between the ages of 18 and 65 years, inclusive at the time of informed consent;
• Body mass index (BMI) of 18.0 to 34.9 kg/m2 inclusive and body weight not less than 50 kg;
• Female participants must have a negative serum pregnancy test result at Screening and negative urine pregnancy test at admission to the study site, are not currently breastfeeding, and meet one of the following criteria:
• Surgically sterile for at least 3 months prior to Screening by one of the following means:
• Bilateral tubal ligation
• Bilateral salpingectomy (with or without oophorectomy)
• Surgical hysterectomy
• Bilateral oophorectomy (with or without hysterectomy)
• Postmenopausal, defined as the following:

You may not qualify if:

• Inability to attend all the study visits or comply with study procedures;
• Evidence of clinically significant history of gastrointestinal, musculoskeletal, endocrine, hematologic, renal, hepatic, neurologic, ophthalmic, immunologic, lipid metabolism disorders, drug hypersensitivity, psychiatric disease and abnormalities or any known history of any gastrointestinal surgery or cholecystectomy that could impact the PK of EQ143 as determined by the Investigator or Sponsor;
• Evidence of clinically significant history of cardiovascular disease, including myocardial infarction, unstable angina, Torsade de Pointes, clinically significant arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), symptomatic congestive heart failure (New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism or other clinically significant episode of thromboembolic disease;
• A history of additional risk factors for Torsade de Pointes (eg, heart failure, hypokalemia, family history of Long QT Syndrome);
• Evidence of clinically significant history of bronchopulmonary disease, including interstitial lung disease (ILD), drug induced ILD, radiation pneumonia requiring steroid treatment and clinical evidence of active ILD;
• Hospital admission or major surgery within 3 months prior to Screening;
• A history of prescription drug abuse, or illicit drug use within 6 months prior to Screening;
• A history of alcohol abuse according to medical history within 6 months prior to Screening;
• A history of organ transplant, including history of bone marrow transplant;
• Taken any prescription medications (excluding contraceptives) within 14 days or 5 half-lives (whichever is longer) of the study dose or taken an investigational drug within 3 months or 5 half-lives, whichever is longer, from the Screening date;
• Evidence of hypertension stage 2, defined as a systolic BP \> 140 mmHg and a diastolic BP \> 90 mmHg at Screening. Blood pressure measurement should be performed in triplicate if initial results exceed these values, and the average value should be used to determine eligibility;
• Fever (body temperature \> 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening. PCR testing for SARS-CoV-2 infection will be performed in accordance with local guidelines (health authorities, Institutional Review Boards/Independent Ethics Committees, and study center policies) and at the discretion of the Investigator, if required;
• Any of the following ECG criteria at Screening or Admission:
• PR interval \> 220 ms or \< 110 ms;
• QRS interval \> 120 ms;

Sponsors & Collaborators

• EQRx, Inc.: lead

Study Sites (2)

Spaulding Clinical Research

West Bend, Wisconsin, 53095, United States

Location

New Zealand Clinical Research

Auckland, New Zealand

Location

MeSH Terms

Interventions

aumolertinib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 21, 2021
• Study Start: June 21, 2021
• Primary Completion: October 7, 2021
• Study Completion: October 7, 2021
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

US (1); NZ (1)