Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT03716427
Eligibility Criteria:
Inclusion Criteria:
1. Willing and able to provide written informed consent prior to initiation of any study-related procedures.
2. Men and women ≥ 18 and ≤ 55 years of age
3. In good health as determined by medical history, physical exam, laboratory examinations, ECG, and vital signs
4. BMI between 18 and 35 kg/m2, inclusive
5. Have a normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction
6. Non-smokers; defined as not having smoked in the previous 6 months
7. Women who are neither pregnant (negative pregnancy test) nor nursing, and are either:
1. Surgically sterile (bilateral tubal ligation, hysterectomy), or
2. Postmenopausal with last natural menses greater than 12 months, or
3. Premenopausal and using an acceptable barrier form of birth control from screening until two-weeks post discharge. Acceptable forms of birth control include abstinence and any double combination of: hormonal contraceptive, intrauterine device (IUD), male or female condom, diaphragm, sponge, and cervical cap. Spermicides may be used, but is not considered one of the required double barrier methods. All premenopausal female subjects (regardless of whether they are surgically sterile) must have a negative serum pregnancy test at screening and baseline.
Exclusion Criteria:
1. Known hypersensitivity or allergy to omeprazole, tolbutamide, dextromethorphan, midazolam, or CT1812
2. Absence of one functional allele for CYP2D6, CYP2C9 or CYP2C19 at screening
3. Any disease or condition (medical or surgical) which, in the opinion of the Investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
4. The presence of abnormal laboratory values which are considered clinically significant
5. Positive screen for Hepatitis B (HbsAg, Hepatitis B Surface Antigen), Hepatitis C (anti HCV, Hepatitis C Antibody), or HIV (anti-HIV 1/2)
6. Received an investigational drug within a period of 30 days prior to enrollment in the study
7. Received any drug therapy within 2 weeks prior to administration of the first dose of any study-related treatment. This exclusion is extended to 4 weeks for any drugs known to induce or inhibit hepatic drug metabolism.
8. Consumption of alcohol within 14 days prior to dose administration or during any in-patient period
9. A positive urine drug screen including ethanol, cocaine, THC, barbiturates, amphetamines, benzodiazepines, and opiates
10. Any history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid within the past two years, or any history of drug abuse or addiction within the past two years
11. A history of difficulty with donating blood
12. Donated whole blood within 45 days or blood products within 7 days prior to enrollment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03716427
Study Brief:
Protocol Section:
NCT03716427