A Phase I, Two-part, Single and Optional Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of 500 and 750 mg PXL770 in Healthy Subjects

Poxel SA1 site in 1 country16 target enrollmentMarch 8, 2021

ConditionsNASH - Nonalcoholic Steatohepatitis

InterventionsPXL770

DrugsPXL770

Overview

Phase: Phase 1
Intervention: PXL770
Conditions: NASH - Nonalcoholic Steatohepatitis
Sponsor: Poxel SA
Enrollment: 16
Locations: 1
Primary Endpoint: Cmax
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study was planned in 2 parts: Parts A and B. In Part A, we tested 2 single doses of the study medicine in healthy volunteers: 500 mg and 750 mg. Part B was an optional part to test once-daily doses of the study medicine in healthy volunteers. We aimed to assess the safety, tolerability find out the side effects and blood levels of the PXL770.

Registry

clinicaltrials.gov

Start Date

March 8, 2021

End Date

March 29, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Poxel SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female healthy volunteer.
•Aged 18-55 years.
•A body mass index in the range 18.5-29.
•Body weight at least 50 kg.
•Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
•Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or their delegate.
•Agree to follow the contraception requirements of the trial.
•Agree not to donate blood or blood products during the study and for up to 3 months after the administration of the trial medication.
•Willingness to give written consent
•Registered with a General Practitioner in the UK.

Exclusion Criteria

•Woman who is pregnant or lactating, or pre-menopausal woman who is sexually active and not using a reliable method of contraception.
•Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
•Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.
•Estimated glomerular filtration rate at screening \< 90 mL/min/1.73 m2 (estimated using the method established by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\]).
•History of drug-induced Torsade de Pointes, or known risk factors for Torsade de Points (heart failure, hypokalemia, short QT syndrome, family history of long QT Syndrome, or QTcF \> 450 msec (men) or \> 470 msec (women). Triplicate QTcF measurements will be taken at screening, and a mean QTcF value higher than 450 msec (men) or 470 msec (women) will lead to exclusion. A repeat (in triplicate) is allowed on one occasion for determination of eligibility.
•Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness.
•Surgery (stomach bypass) or medical condition that might affect absorption of medicines.
•Presence or history of severe adverse reaction to any drug or a history of sensitivity to PXL770, or its excipients.
•Presence or history of anaphylactic or anaphylactoid reaction or food allergy.
•Use of a prescription medicine (except oral contraceptives or hormone replacement therapy in women), over-the-counter medicine with the exception of acetaminophen (paracetamol), dietary supplement or herbal remedy during the 14 days before the first dose of trial medication.

Arms & Interventions

PXL770 500 and 750 mg

Each subject received 1 dose of PXL770 at 500 mg and 1 dose at 750 mg

Intervention: PXL770