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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT03464058
Eligibility Criteria:
Inclusion Criteria:
* Healthy males or healthy females of non-child bearing potential
* Age 18 to 50 years of age at time of signing informed consent
* Body mass index of 18.0 to 32.0 kilograms per meters squared (kg/m\^2) at Screening, or, if outside the range, considered not clinically significant by the investigator
* Must be willing and able to communicate and participate in the whole study
* Must have a negative Quantiferon tuberculosis test at Screening
* Must provide written informed consent
* Must agree to use an adequate method of contraception
Exclusion Criteria:
* Participants who have received any investigational medicinal product (IMP) in a clinical research study within the previous 3 months prior to dosing
* Participants who are study site employees, or immediate family members of a study site or sponsor employee
* Participants who have previously been enrolled (dosed) in this study
* History of any drug or alcohol abuse in the past 2 years prior to Screening
* Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 milliliters \[mL\] of 40% spirit or a 125 mL glass of wine)
* Current smokers and those who have smoked within the last 12 months prior to Screening. A breath carbon monoxide reading of greater than 20 parts per million at Screening or admission
* Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months prior to Screening
* Females of childbearing potential
* Participants who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at Screening
* Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
* Confirmed positive drugs of abuse test result
* Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results
* Evidence of renal impairment at Screening, as indicated by an estimated creatinine clearance of \<70 mL/minute using the Cockcroft-Gault equation
* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease (including gall stones and/or cholecystectomy), neurological or psychiatric disorder, as judged by the investigator
* Serious adverse reaction or serious hypersensitivity to any drug or the IMP formulation excipients
* Adverse reaction to rabeprazole, its excipients or any proton pump inhibitors (Part 2 only)
* Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
* Donation or loss of greater than 400 mL of blood within the previous 3 months
* Participants who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 grams per day paracetamol or hormone replacement therapy) or herbal remedies in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the Principal Investigator and sponsor's medical monitor.
* Participants who have any ongoing fungal infections (stable toe nail onychomycosis is allowed)
* Failure to satisfy the investigator of fitness to participate for any other reason
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03464058
Study Brief:
Protocol Section:
NCT03464058