A Healthy Volunteer Study to Compare Fezagepras (PBI-4050) With Sodium Phenylbutyrate (NCT05349435) | Clinical Trial Compass
TerminatedPhase 1
A Healthy Volunteer Study to Compare Fezagepras (PBI-4050) With Sodium Phenylbutyrate
Stopped: Sponsor has decided to discontinue development of fezegepras based on initial pharmacokinetic results
United Kingdom8 participantsStarted 2022-05-13
Plain-language summary
The purpose of this study is to compare the safety, tolerability and pharmacokinetic profile of fezagepras (PBI-4050) to that of sodium phenylbutyrate (PBA) when both products are given as single ascending doses to healthy adult subjects.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy, adult, male or female (of non childbearing potential only\*), 18 to 65 years of age, inclusive, at the screening visit.
. Male subjects must follow protocol specified contraception guidance
. Continuous non smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing based on subject self-reporting.
. Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 and body weight of ≥ 50 kg for males and ≥ 45.0 kg for females, at the screening visit.
. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs and ECGs, as deemed by the PI or designee, including the following:
. Able to swallow multiple tablets.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Understands the study procedures in the informed consent form (ICF), able to provide written consent and be willing and able to comply with the protocol to completion of the study (including follow-up visit).
Exclusion criteria
. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
. History or presence of clinically significant medical or psychiatric condition or disease, including but not limited to neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
. History of any illness that might confound the results of the study or pose an additional risk to the subject by their participation in the study.
. History of significant drug abuse within 18 months prior to screening or use of soft drugs (such as marijuana) within 6 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine, crack, opioid derivatives including heroin, and amphetamine derivatives) within 18 months prior to screening.
. Drink alcohol in excess of 21 units per week for males or 14 glasses/units per week for females, with one unit = 150 mL of wine or 360 mL of beer or 45 mL of 45% alcohol.
. History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds.