NSCLC, Healthy Volunteers, Pharmacokinetics
Conditions
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)
Interventions
DRUGaumolertinib
EQ143 tablet is an oral solid dosage form manufactured at a strength of 55 mg
Sponsors
EQRx, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
To be eligible for this study, a participant has to meet all of the following inclusion criteria: 1. Participant self-reports as being of one of the following racial or ethnic groups: 1. being of non-Chinese, European descent 2. having origins in any of the black racial groups of Africa 3. being of Cuban, Mexican, Puerto Rican, Cuban, South or Central American, or other Spanish culture or origin, regardless of race 4. having two Han Chinese biological parents; 2. Is capable of giving informed consent and complying with study procedures; 3. Healthy male or female participants, between the ages of 18 and 65 years, inclusive at the time of informed consent; 4. Body mass index (BMI) of 18.0 to 34.9 kg/m2 inclusive and body weight not less than 50 kg; 5. 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: 1. 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) 2. 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 3. 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. 6. Male participants must agree to utilize a highly effective method of contraception (condom) during heterosexual intercourse from CRU admission until 12 weeks following the final Follow-up visit on Day 10 and must refrain from donating sperm for this same period; 7. Considered healthy by the Investigator, based on participant's reported medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs; 8. Willing and able to adhere to study restrictions and to be confined at the clinical research center; 9. Participants willing to defer receiving prophylactic live immunizations during the duration of the study. Participants may receive vaccination for SARS-CoV-2 at the discretion of the Investigator as soon as they are eligible, and a vaccine is available. If and when possible, the inactivated mRNA-based vaccines are recommended.
Exclusion criteria
A participant who meets any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
New Zealand, United States
Outcome results
None listed