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Single Ascending Dose Study of PBI-4547 in Healthy Subjects

NCT ID: NCT04068259

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-05

Study Completion Date

2019-10-08

Brief Summary

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This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of PBI-4547 in healthy adult participants.

Detailed Description

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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 reported to play a role in fibrosis in various animal models as well as in tissue culture.

A total of 40 healthy adult participants will sequentially receive 1 of 5 doses of PBI-4547 (Dose1, 2, 3, 4 or 5) or matching placebo, with each cohort of 8 participants randomized in a 3:1 ratio to receive PBI-4547 or matching placebo.

A food-effect cohort will be added after review of the PK results of at least the first dose, and the following 2 doses, if needed. In this cohort participants will initially receive the study drug under fasting conditions (Period 1) followed by the same dose after the ingestion of a high-fat meal (Period 2) after a 14-day washout period.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1, Dose 1 of PBI-4547 or Placebo

Dose 1 of PBI-4547 or matching Placebo tablets by mouth

Group Type EXPERIMENTAL

PBI-4547

Intervention Type DRUG

PBI-4547 tablet

Placebo

Intervention Type OTHER

Placebo tablet

Cohort 2, Dose 2 of PBI-4547 or Placebo

Dose 2 of PBI-4547 or matching Placebo tablets by mouth

Group Type EXPERIMENTAL

PBI-4547

Intervention Type DRUG

PBI-4547 tablet

Placebo

Intervention Type OTHER

Placebo tablet

Cohort 3, Dose 3 of PBI-4547 or Placebo

Dose 3 of PBI-4547 or matching Placebo tablets by mouth

Group Type EXPERIMENTAL

PBI-4547

Intervention Type DRUG

PBI-4547 tablet

Placebo

Intervention Type OTHER

Placebo tablet

Cohort 4, Dose 4 of PBI-4547 or Placebo

Dose 4 of PBI-4547 or matching Placebo tablets by mouth

Group Type EXPERIMENTAL

PBI-4547

Intervention Type DRUG

PBI-4547 tablet

Placebo

Intervention Type OTHER

Placebo tablet

Cohort 5, Dose 5 of PBI-4547 or Placebo

Dose 5 of PBI-4547 or matching Placebo tablets by mouth

Group Type EXPERIMENTAL

PBI-4547

Intervention Type DRUG

PBI-4547 tablet

Placebo

Intervention Type OTHER

Placebo tablet

Interventions

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PBI-4547

PBI-4547 tablet

Intervention Type DRUG

Placebo

Placebo tablet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Syneos Health

OTHER

Sponsor Role collaborator

Liminal BioSciences Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Moran, MD

Role: STUDY_DIRECTOR

Prometic Pharma SMT Ltd.

Richard Larouche, MD

Role: PRINCIPAL_INVESTIGATOR

Syneos Health

Locations

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Syneos Health

Montreal, Quebec, Canada

Site Status

Syneos Health

Québec, , Canada

Site Status

Countries

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Canada

References

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Leduc M, Grouix B, Tremblay M, GervaisL, Sarra-Bournet F, Felton X, Simard J, Leblond FA, Laurin P and Gagnon L. PBI-4547 Improves Glucose Metabolism and Insulin Resistance, and Reduces Liver Damage in a High-Fat Diet Mouse Model of Obesity and Metabolic Syndrome. Diabetes 2018 Jul; 67(Supplement 1).

Reference Type BACKGROUND

Gagnon L, Laverdure A, Sarra-Bournet F, Cloutier M, Felton A, Treemblay M, Richard J, Gervais L, Laurin P, Leblond FA and Grouix B. PBI-4547 Reverses Diabetes and Metabolic Syndrome through Regulation of Lipid/Glucose Metabolism, ß-Oxidation and Fibrosis in Liver, and White Adipose Tissue in ob/ob Mice. Diabetes 2018 Jul; 67(Supplement 1).

Reference Type BACKGROUND

Sarra-Bournet F, Grouix B, Hince K, Felton A, Tremblay M, Abbott S, Duceppe JS, Zacharie B, Laurin P, Gagnon G. PBI-4547 decreases hepatic stellate cell activation via AMPK signaling pathway, and reduces fibrosis in carbon tetrachloride (CCL4)-induced hepatic fibrosis model. Journal of Hepatology 2018, 68:S365-S604.

Reference Type BACKGROUND

Other Identifiers

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180271

Identifier Type: OTHER

Identifier Source: secondary_id

PBI-4547-CT-9-01

Identifier Type: -

Identifier Source: org_study_id