Status:
TERMINATED
Single Ascending Dose Study of PBI-4547 in Healthy Subjects
Lead Sponsor:
Liminal BioSciences Ltd.
Collaborating Sponsors:
Syneos Health
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of PBI-4547 in healthy adult participants.
Detailed Description
This is a first-in-human, single-ascending dose study of PBI-4547 in healthy adult participants. PBI-4547 is a synthetic ligand of G protein-coupled receptor (GPR)40 and GPR84, which have been reporte...
Eligibility Criteria
Inclusion
- Healthy male participants or non-childbearing potential female participants, ≥18 and ≤55 years.
- Body mass index \> 18.5 and \< 30.0 kg/m\^2, and body weight ≥ 50.0 kg for male participants and ≥ 45.0 kg for female participants.
- Continuous non-smoker who has not used tobacco or nicotine-containing products for at least 3 months prior to screening.
- Male participants with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after study drug administration.
- Male participants must be willing not to donate sperm until 90 days after study drug administration.
Exclusion
- Any clinically significant abnormality or abnormal laboratory test results.
- An estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m\^2.
- Positive urine drug screen and history of significant drug abuse.
- History of significant allergic reactions to any drug.
- Use of any drugs known to induce or inhibit hepatic drug metabolism.
- Positive pregnancy test or breast-feeding participant.
- Clinically significant abnormalities in ECG, blood pressure, and heart rate at screening.
- History of significant alcohol abuse or regular use of alcohol.
- Use of medication other than topical products without significant systemic absorption.
- Donation of plasma.
Key Trial Info
Start Date :
September 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04068259
Start Date
September 5 2019
End Date
October 8 2019
Last Update
December 8 2020
Active Locations (2)
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1
Syneos Health
Montreal, Quebec, Canada, H3X 2H9
2
Syneos Health
Québec, Canada, G1P 0A2