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:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
NCT ID:
NCT04443192
Eligibility Criteria:
Inclusion Criteria:
* Part A: healthy Caucasian males or females, aged 18-65 years at the time of consent; Part B: males or females of general good health, aged 18-72 years at the time of consent.
* Body mass index of 18.0-30.0 kg/m\^2 (Part A) and 18.0-35.0 kg/m\^2 (Part B).
* Able to understand the nature of the trial and any hazards of participating in it. Able to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of the entire trial
* Willing to give written fully informed consent to participate
* Agree to follow the contraception requirements of the trial
* Agree not to donate blood or blood products during the study and for up to 3 months after the trial medication
* Registered with a General Practitioner in the United Kingdom
* Willing to give written consent to have data entered into The Over-volunteering Prevention System \[Part B only\]
* Confirmed genotype with at least one Z alpha-1-antitrypsin allele (PiXZ)
Exclusion Criteria:
* Woman who is pregnant or lactating, or woman of child-bearing potential who is sexually active and not using a highly effective method of contraception
* Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer
* Acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous
* Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness
* Creatinine clearance \<60 mL/min/1.73m2
* Active cancer or to be actively on cancer therapy, or diagnosis of cancer (except for Basal Cell Carcinoma, Squamous Cell Carcinoma (fully excised), or Cervical Intra-epithelial Neoplasia in situ) in the 5 years before the first dose of trial medication.
* Surgery (eg stomach bypass) or medical condition that might affect absorption of medicines
* Presence or history of severe adverse reaction to any relevant drug
* During the 28 days before the first dose of trial medication, the use of prescription medicine judged by the investigator to have the potential to influence the results of the study; or during the 7 days before the first dose of trial medication, the use of a herbal supplement or an over-the-counter medicine, with the exception of ibuprofen
* Receipt of a COVID-19 vaccine within 14 days before the first dose of trial medication; exhibition of symptoms suspected to be related to COVID-19 within 28 days before the first dose of trial medication; or receipt of a positive COVID-19 test during the 28 days before the first dose of trial medication
* Receipt of an investigational product (including prescription medicines) as part of another clinical trial within 3 months before admission to this study; in the follow-up period of another clinical trial at the time of screening for this study
* Recent drug or alcohol abuse (within 2 years before screening), or intake of more than 3 units of alcohol daily (for men) or 2 units of alcohol daily (for women); or use of cigarettes or nicotine-containing products during 30 days before the first dose of trial medication until the end of the study
* Blood pressure and heart rate in supine position at the screening examination outside the ranges: blood pressure 90-160 mm Hg systolic, 40-90 mm Hg diastolic; heart rate 40-100 beats/min
* Possibility that the volunteer will not cooperate with the requirements of the protocol
* Evidence of drug abuse on urine testing
* Positive test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus
* Loss of more than 400 mL blood during 3 months before the trial, eg as a blood donor
* Objection by General Practitioner to volunteer entering trial
Part A, Cohort 7 only:
\- Vegans, vegetarians, or unwilling to eat a high-fat breakfast containing bacon.
Part B only:
\- Undergone liver transplantation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
72 Years
Study:
NCT04443192
Study Brief:
Protocol Section:
NCT04443192