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A Healthy Volunteer Study to Compare Fezagepras (PBI-4050) With Sodium Phenylbutyrate

NCT05349435 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-08-01

No results posted yet for this study

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.

Conditions

  • Hyperammonemia

Interventions

DRUG

Fezagepras

Investigational drug

DRUG

Sodium phenylbutyrate

Investigational drug

Sponsors & Collaborators

  • Liminal BioSciences Ltd.

    lead INDUSTRY

Principal Investigators

  • Sami Omar · Liminal BioSciences Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-13
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05349435 on ClinicalTrials.gov