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

Completed · Phase 1

Conditions studied: NSCLC, Healthy Volunteers, Pharmacokinetics

In brief

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)

Key facts

Study ID

NCT04969965

Run by

EQRx, Inc.

People needed

45

Starts

2021-06-21

Expected to finish

2021-10-07

Last updated by the study team

2022-06-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• To be eligible for this study, a participant has to meet all of the following inclusion criteria:
• 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:
• Last menstrual period greater than 12 months prior to Screening without an alternative medical cause, AND
• Postmenopausal status confirmed by serum Follicle-stimulating hormone (FSH) concentration at Screening > 40 mIU/mL
• Female participants of childbearing potential must use at least one of the following protocol-specified highly effective methods of birth control, AND must agree to use barrier contraception (male condom) during heterosexual intercourse, from the time of Screening until at least 90 days after EQ143 treatment:
• Infertile male partner (eg, vasectomy [at least 6 months prior to Screening; vasectomized partner should be the sole partner of the female participant], permanently sterile following bilateral orchidectomy, or any other documented cause of infertility)
• Combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal, injectable)
• Progestogen-only hormonal contraception (oral, injectable, implantable)
• Implantable device (implantable rod or intrauterine device)
• Bilateral tubal occlusion Alternatively, females of childbearing potential must practice complete abstinence (defined as refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the participant; periodic abstinence and withdrawal are not acceptable) from Screening until at least 90 days after EQ143 treatment. It is not necessary to use any other method of contraception when complete abstinence is elected. Women of childbearing potential (WOCBP) who choose complete abstinence must continue to have pregnancy tests as per protocol. The reliability of sexual abstinence needs to be evaluated by the Investigator in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.
• Participants must agree to not donate sperm or ova from time of EQ143 administration until 90 days after EQ143 treatment.

You may not qualify if…

• A participant who meets any of the following exclusion criteria must be excluded from the study:
• 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;
• Female participants of childbearing potential except as permitted by 5 a, b, or c under inclusion criteria;
• 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;
• QTcF interval > 450 ms in males and > 480 ms in females;
• A marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval > 450 ms)
• ST segment elevation or depression considered to be clinically significant by the Investigator or designee;
• T-wave abnormalities considered to be clinically significant by the Investigator or designee; If the QTcF interval exceeds 450 ms (males) or 480 ms (females), or the QRS interval exceeds 120 ms, the ECG should be repeated in triplicate and the average of the 3 QTcF or QRS values should be used to determine the patient's eligibility.
• Impaired renal function as determined by Investigator following review of clinical laboratory test results (ie, estimated glomerular filtration rate [eGFR] less than 90 mL/min/1.73m2, as calculated using the method standard for the institution);
• Any of the following safety laboratory findings at Screening or Admission:
• Absolute neutrophil count < 1.5 × 109/L
• Platelet count < 100 × 109/L

Where it is running

• Spaulding Clinical Research — West Bend, Wisconsin, United States
• New Zealand Clinical Research — Auckland, New Zealand

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.