NASH - Nonalcoholic SteatohepatitisPhase 1NCT05441904

Study to Assess the Safety, Tolerability, and Pharmacokinetics of PXL770 in Healthy Subjects.

A Phase 1 study testing PXL770 in people with NASH - Nonalcoholic Steatohepatitis, run by Poxel SA at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: NASH - Nonalcoholic Steatohepatitis
What is being tested?: PXL770
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited Kingdom
Study dates: 8 Mar 2021to 29 Mar 2021
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female healthy volunteer.
Aged 18-55 years.
A body mass index in the range 18.5-29.9.
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.

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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.

Who cannot join

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.

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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.
Receipt of an investigational product (including prescription medicines) as part of another clinical trial within the 3 months before first admission to this study; in the follow-up period of another clinical trial at the time of screening for this study.
Have previously taken PXL770 in another clinical trial.
Presence or history of drug or alcohol abuse, or intake of more than 14 units of alcohol weekly, or more than 5 cigarettes, 1 cigar or pipe (about ¼ ounce tobacco) daily.
Regular consumption of more than 5 cups of caffeinated drinks (or equivalent) daily.
Blood pressure and heart rate in supine position at the screening examination outside the ranges: blood pressure 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate 40-100 beats/min. Borderline values (ie values that are within 5 mm Hg for blood pressure or 5 beats/min for heart rate) will be repeated in triplicate. Subjects can be included if the repeat value is within range or still borderline but deemed not clinically significant by the investigator.
Vegetarians or vegans, or unwilling to eat up to two breakfasts including bacon.
Possibility that the volunteer will not cooperate with the requirements of the protocol.
Evidence of drug abuse on urine testing, or positive urine alcohol test.
Positive test for hepatitis B, hepatitis C or human immunodeficiency virus (HIV). Participants with positive hepatitis C antibody due to prior resolved disease can be included if the hepatitis C ribonucleic acid (RNA) test is obtained and the result is negative.
Loss of more than 550 mL blood during the 3 months before the trial.
Objection by General Practitioner to volunteer in the trial.
Involved in the planning or conduct of the study at Poxel S.A. or HMR.
Considered a vulnerable person (a prisoner on probation, for example).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

HMR
London, NW10, 7EW

Other trials in United Kingdom

About this study

Official title: 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

Conditions: NASH - Nonalcoholic Steatohepatitis
Being tested: PXL770
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PXL770Drug
A single dose of 500 and 750 mg was administered to each subject.

Study groups in NCT05441904
Study group	Role	What they receive
PXL770 500 and 750 mg	Experimental	Each subject received 1 dose of PXL770 at 500 mg and 1 dose at 750 mg Receives: Drug: PXL770

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
maximum concentration
Measured: Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose.
AUC
area under the curve
Measured: Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose.
t1/2
half-life
Measured: Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose.
tmax
time to reach maximum concentration
Measured: Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose.
MRT
mean residence time
Measured: Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose.
CL/F
apparent clearance
Measured: Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose.
Vz/F
volume of distribution
Measured: Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose.

Secondary outcomes (1)

AE
Adverse events
Measured: Safety monitoring will be done from the date of signature of the ICF until the end of the study, assessed up to 5 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Mar 202129 Mar 2021

First posted1 Jul 2022
Study start8 Mar 2021
Primary completion29 Mar 2021
Study completion29 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05441904
Sponsor's protocol ID: PXL770-009
Status last verified: Jun 2022
First submitted: 22 Jun 2022
Last updated: 1 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
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A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
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Target of Suv420h1/2 in Hepatocytes
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Active, not recruitingPhase 3
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
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Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
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All NASH - Nonalcoholic Steatohepatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05441904
Acronym / sponsor ID: PXL770-009
Conditions: NASH - Nonalcoholic Steatohepatitis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Poxel SAIndustry (pharma, biotech, devices)
Study start: 8 Mar 2021 (actual)
Primary completion: 29 Mar 2021 (actual)
Study completion: 29 Mar 2021 (actual)
First posted: 1 Jul 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PXL770 500 and 750 mg	Experimental	Drug: PXL770Each subject received 1 dose of PXL770 at 500 mg and 1 dose at 750 mg

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Male or female healthy volunteer.
Aged 18-55 years.
A body mass index in the range 18.5-29.9.
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.

Key exclusion criteria (23 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PXL770A single dose of 500 and 750 mg was administered to each subject.	Drug	PXL770 500 and 750 mg

Primary outcome

Cmax
Time frame: Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose.
maximum concentration
AUC
Time frame: Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose.
area under the curve
t1/2
Time frame: Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose.
half-life
tmax
Time frame: Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose.
time to reach maximum concentration
MRT
Time frame: Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose.
mean residence time
CL/F
Time frame: Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose.
apparent clearance
Vz/F
Time frame: Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose.
volume of distribution

1 secondary outcome

AE
Time frame: Safety monitoring will be done from the date of signature of the ICF until the end of the study, assessed up to 5 weeks.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
Individual participant dataSharing planned: No

Related trials for NASH - Nonalcoholic Steatohepatitis

RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
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Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PXL770 in people with NASH - Nonalcoholic Steatohepatitis, run by Poxel SA at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05441904.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.