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A Healthy Volunteer Study of PBI-4050

NCT04695041 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2021-11-30

No results posted yet for this study

Summary

The purpose of this study is to investigate the study drug PBI-4050 to determine the safety, tolerability and concentration profile in the blood when the drug is given to healthy volunteers as multiple doses and different dosing regimens over a period of 14 days.

Conditions

Interventions

DRUG

PBI-4050/ Placebo

Participants receive either 800mg PBI-4050 capsules or placebo, twice a day for 14 days

DRUG

PBI-4050/ Placebo

Participants receive either 1200mg PBI-4050 capsules or placebo, once a day for 14 days

DRUG

PBI-4050/ Placebo

Participants receive either 1000 mg PBI-4050 capsules or placebo, twice a day for 14 days

DRUG

PBI-4050/ Placebo

Participants receive either 1200 mg PBI-4050 capsules or placebo, twice a day for 14 days

DRUG

PBI-4050/ Placebo

Participants receive either 800 mg PBI-4050 capsules or placebo, three times a day for 14 days

Sponsors & Collaborators

  • Liminal BioSciences Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-12-09
Primary Completion
2021-10-05
Completion
2021-10-05

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT04695041 on ClinicalTrials.gov