NCT04068259

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

September 5, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2019

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

1 month

First QC Date

August 22, 2019

Last Update Submit

December 7, 2020

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (5)

  • Number of participants with treatment-emergent adverse events (TEAEs)

    TEAE is any untoward medical occurrence in a subject who has been administered a pharmaceutical product or not, which does not necessarily have a causal relationship with this treatment.

    5-6 days

  • Number of participants with clinically significant laboratory evaluation findings

    Laboratory tests for hematology, serum chemistry and urinalysis will be performed upon admission, at discharge, and at the follow-up visit (5 ± 1 day post-dose).

    5-6 days

  • Number of participants with clinically significant electrocardiogram (ECG) Findings

    Triplicate ECG will be performed upon admission, pre-dose, and approximately 1, 2, 8, and 24 hours post-dose, and at the follow-up visit (5 ± 1 day post-dose). Subjects will be continuously monitored using a Holter monitor from approximately 1 hour pre-dose until approximately 24 hours post-dose.

    5-6 days

  • Number of participants with clinically significant vital sign findings

    Vital signs include blood pressure, heart rate, respiratory rate, and oral body temperature will be measured upon admission, before discharge from the clinic and at the follow-up visit (5 ± 1 day post-dose).

    5-6 days

  • Number of participants with physical examination findings

    Brief physical examination will be conducted upon admission and at discharge. A complete physical examination will be conducted at screening and follow-up visit.

    5-6 days

Secondary Outcomes (15)

  • AUC0-t for PBI-4547

    48 hours

  • AUC0-inf for PBI-4547

    48 hours

  • Cmax for PBI-4547

    48 hours

  • Residual area for PBI-4547

    48 hours

  • Tmax for PBI-4547

    48 hours

  • +10 more secondary outcomes

Study Arms (5)

Cohort 1, Dose 1 of PBI-4547 or Placebo

EXPERIMENTAL

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

Drug: PBI-4547Other: Placebo

Cohort 2, Dose 2 of PBI-4547 or Placebo

EXPERIMENTAL

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

Drug: PBI-4547Other: Placebo

Cohort 3, Dose 3 of PBI-4547 or Placebo

EXPERIMENTAL

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

Drug: PBI-4547Other: Placebo

Cohort 4, Dose 4 of PBI-4547 or Placebo

EXPERIMENTAL

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

Drug: PBI-4547Other: Placebo

Cohort 5, Dose 5 of PBI-4547 or Placebo

EXPERIMENTAL

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

Drug: PBI-4547Other: Placebo

Interventions

PBI-4547DRUG

PBI-4547 tablet

Cohort 1, Dose 1 of PBI-4547 or PlaceboCohort 2, Dose 2 of PBI-4547 or PlaceboCohort 3, Dose 3 of PBI-4547 or PlaceboCohort 4, Dose 4 of PBI-4547 or PlaceboCohort 5, Dose 5 of PBI-4547 or Placebo
PlaceboOTHER

Placebo tablet

Cohort 1, Dose 1 of PBI-4547 or PlaceboCohort 2, Dose 2 of PBI-4547 or PlaceboCohort 3, Dose 3 of PBI-4547 or PlaceboCohort 4, Dose 4 of PBI-4547 or PlaceboCohort 5, Dose 5 of PBI-4547 or Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Syneos Health

Montreal, Quebec, H3X 2H9, Canada

Location

Syneos Health

Québec, G1P 0A2, Canada

Location

Related Publications (3)

  • 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).

    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).

    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.

    BACKGROUND

MeSH Terms

Interventions

PBI-4547

Study Officials

  • John Moran, MD

    Prometic Pharma SMT Ltd.

    STUDY DIRECTOR

  • Richard Larouche, MD

    Syneos Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 28, 2019

Study Start

September 5, 2019

Primary Completion

October 8, 2019

Study Completion

October 8, 2019

Last Updated

December 8, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)