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 range18 Years – 65 Years
SexALL
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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.
✓. 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.