None listed
Conditions
Brief summary
The study to evaluate the relative oral bioavailability, safety, and tolerability of EQ121 ER tablet formulations and an EQ121 IR capsule formulation in adult healthy volunteers of Chinese descent. Participants will be randomized in 1:1 ratio to 1 of 2 sequences. The ER tablet formulation will be used. Part C will enroll approximately 10 adult healthy volunteers of Chinese descent, defined as participants with both parents and both grandparents of Chinese ancestry.
Interventions
EQ121 immediate release (IR) capsule is an oral solid dosage form manufactured at strengths of 1 mg and 12 mg.
Each EQ121 capsule contains EQ121 drug substance; mannitol, pregelatinized starch and microcrystalline cellulose as diluents; croscarmellose sodium as disintegrant; colloidal silicon dioxide as glidant; and magnesium stearate as lubricant
Part C is a two-sequence, two-period crossover study to compare the oral bioavailability of the EQ121 IR capsule formulation to the EQ121 ER tablet fo
EQ121 immediate release (IR) capsule is an oral solid dosage form manufactured at strengths of 1 mg and 12 mg. Each EQ121 capsule contains EQ121 drug substance; mannitol, pregelatinized starch and microcrystalline cellulose as diluents; croscarmellose sodium as disintegrant; colloidal silicon dioxide as glidant; and magnesium stearate as lubricant Part C is a two-sequence, two-period crossover study to compare the oral bioavailability of the EQ121 IR capsule formulation to the EQ121 ER tablet formulation, in adult healthy volunteers of Chinese descent Sequence 1: In period 1 of Sequence 1, the participants will receive 2 oral doses of 24 mg EQ121 immediate release (IR) capsule given twice a day (e.g. 12 hours apart) on Day 1 under fasting conditions. Sequence 2: In period 2 of Sequence 2, after completion of Period 1, following a 5-day washout period, the same participants will receive 2 oral doses of 24 mg EQ121 immediate release (IR) capsule given twice a day (e.g. 12 hours apart) on Day 7 under fasting conditions Five (5) participants will be enrolled into each sequence Adherence will be monitored via clinical site staff recording and reporting all number of pills taken while confined
Sponsors
EQRx International, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Are capable of giving informed consent and complying with study procedures; 2. Healthy male or female participants, between the ages of 18 and 65 years, inclusive; 3. BMI of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg; 4. Female participants must not be currently breast-feeding, and must meet one of the following criteria: a. 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) b. 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 FSH concentration at Screening greater than 40 mIU/mL c. Women of childbearing potential (WOCBP): • Must not have a positive serum pregnancy test at Screening and must have a negative urine pregnancy test on admission • 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 30 days after the last dose of study drug: • Partner vasectomy (at least 6 months prior to Screening; vasectomized partner should be the sole partner of the female participant) • 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) Alternatively, WOCBP 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 30 days after the last dose of study drug. It is not necessary to use any other method of contraception when complete abstinence is elected. 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 PI or designee in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. 5. Male participants must agree to utilize a highly effective method of contraception (condom) during heterosexual intercourse from clinic admission until 90 days following the last dose of study drug and must refrain from donating sperm for this same period. Vasectomized males do not need to use additional forms of contraception providing that the procedure was performed at least 12 weeks prior to Screening and an absence of sperm in the ejaculate has been documented. Total sexual abstinence may be considered acceptable at the discretion of the PI or designee; 6. Considered healthy by the PI or designee, based on participant’s reported medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;
Exclusion criteria
1. Inability to attend all the study visits or comply with study procedures; 2. Evidence or clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the PI or designee; 3. Hospital admission or major surgery within 3 months prior to Screening; 4. A history of drug abuse, or a positive test at Screening or Admission for drugs of abuse; 5. A history of alcohol abuse according to medical history within 6 months prior to Screening (drinking 14units of alcohol per week: 1 unit equal to 360 mL of beer, or 37 mL of spirits, or 120 mL of wine) at Screening or upon admission to the clinical site; 6. Positive screen for drugs of abuse or alcohol at Screening or at Admission; 7. A history of organ transplant, including history of bone marrow transplant; 8. Taken any prescription medications within 14 days or 5 half-lives (whichever is longer), or any injectable prescription medications within 30 days or 10 half-lives (whichever is longer), of the first dose of study drug 9. Taken an investigational drug within 3 months or 5 half-live, whichever is longer, from the Screening date 10. Any liver LFT value greater than 1.5 of ULN which includes aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, alkaline phosphatase, and gamma-glutamyl transferase (GGT) at Screening or at Admission 11. Any white blood cell (WBC), absolute neutrophil count (ANC), hemoglobin, or platelet count less than the lower limit of normal at Screening or at Admission that is clinically significant in the opinion of the PI or designee 12. Serum creatinine more than upper limit of normal (ULN) at Screening or Admission 13. Any condition or finding that in the opinion of the PI or designee would put the participant or study conduct at risk if the participant were to participate in the study
Outcome results
None listed