Nonalcoholic Fatty LiverPhase 1NCT03950882
A Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With NAFLD
A Phase 1 study testing PXL770 in people with Nonalcoholic Fatty Liver, run by Poxel SA at 1 site in United States.
Trial summary
This study will assess the pharmacokinetics of PXL770 after 4 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonalcoholic Fatty Liver
- What is being tested?
- PXL770
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 31 Mar 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects have given written informed consent
- Body mass index (BMI): ≥ 25 kg/m²
- Hepatic steatosis (CAP ≥ 300)
- Insulin-resistant but not diabetic subjects
- Fasting plasma glucose <126 mg/dL
- Glomerular filtration rate (eGFR) ≥ 60 mL/[min*1.73 m²]
- Alanine amino transferase (ALT) > 20 IU/L in females and > 30 IU/L in males
- Effective contraception
Who cannot join
- Evidence of another form of liver disease
- Evidence of liver cirrhosis
- Evidence of hepatic impairment
- Positive serologic evidence of current infectious liver disease
- History of excessive alcohol intake
- Acute cardiovascular disease with 24 weeks prior to screening
Show all 10Show fewer
- Uncontrolled high blood pressure
- Any disease which in the Investigator's opinion which in the Investigator's opinion would exclude the patient from the study
- Use of non-permitted concomitant medication
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
High Point Clinical Trials Center
High Point, North Carolina, 27265
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
This study will assess the pharmacokinetics of PXL770 after 4 weeks of treatment.
Read the detailed description
The study will be performed in subjects with Nonalcoholic Fatty Liver Disease. The primary endpoint will be the assessment of PXL770 exposure in plasma.
- Conditions
- Nonalcoholic Fatty Liver
- Being tested
- PXL770, Placebo
- 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
Oral capsule
PlaceboDrug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| PXL770 | Experimental | PXL770 500 mg once daily (QD) for 4 weeks Receives: Drug: PXL770; Drug: Placebo |
| Placebo | Placebo comparator | placebo once daily (QD) for 4 weeks Receives: Drug: PXL770; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters of PXL770
AUC : Area under the plasma concentration curve
Measured: Day 26
Secondary outcomes (13)
Plasma PK parameters of PXL770
Minimum plasma concentration (Cmin)
Measured: Day 26
Plasma PK parameters of PXL770
Average plasma concentration (Cavg)
Measured: Day 26
Plasma PK parameters of PXL770
Time to maximum plasma concentration (Tmax)
Measured: Day 26
Plasma PK parameters of PXL770
Apparent volume of distribution (Vz/F)
Measured: Day 26
Plasma PK parameters of PXL770
Apparent oral drug clearance at steady state (CLss/F)
Measured: Day 26
Plasma PK parameters of PXL770
Elimination rate constant (λz)
Measured: Day 26
Plasma PK parameters of PXL770
Terminal elimination half-life (t½)
Measured: Day 26
Plasma PK parameters of PXL770
Area under the concentration-time curve from time 0 to last observed concentration (AUClast)
Measured: Day 26
Plasma PK parameters of PXL770
Food effect: Cmax
Measured: Day 14 and Day 26
Plasma PK parameters of PXL770
Food effect: AUCtau
Measured: Day 14 and Day 26
Plasma PK parameters of PXL770
Food effect: Tmax
Measured: Day 14 and Day 26
Plasma PK parameters of PXL770
PK profile during OGTT: AUCtau
Measured: Day 27
Plasma PK parameters of PXL770
PK profile during OGTT: Cmax
Measured: Day 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Aug 2019
- Primary completion29 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic Fatty LiverStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poxel SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950882
- Sponsor's protocol ID
- PXL770-003
- Status last verified
- Jun 2021
- First submitted
- 13 May 2019
- Last updated
- 11 Jun 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Fouqueray P, Bolze S, Dubourg J, Hallakou-Bozec S, Theurey P, Grouin JM, Chevalier C, Gluais-Dagorn P, Moller DE, Cusi K. Pharmacodynamic effects of direct AMP kinase activation in humans with insulin resistance and non-alcoholic fatty liver disease: A phase 1b study. Cell Rep Med. 2021 Dec 21;2(12):100474. doi: 10.1016/j.xcrm.2021.100474. eCollection 2021 Dec 21.
PubMed 35028615
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT03950882
- Acronym / sponsor ID
- PXL770-003
- Conditions
- Nonalcoholic Fatty Liver
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Poxel SAIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 29 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 15 May 2019 (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.
This study will assess the pharmacokinetics of PXL770 after 4 weeks of treatment.
Detailed description
The study will be performed in subjects with Nonalcoholic Fatty Liver Disease. The primary endpoint will be the assessment of PXL770 exposure in plasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PXL770 | Experimental | Drug: PXL770, Drug: PlaceboPXL770 500 mg once daily (QD) for 4 weeks |
| Placebo | Placebo comparator | Drug: PXL770, Drug: Placeboplacebo once daily (QD) for 4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects have given written informed consent
- Body mass index (BMI): ≥ 25 kg/m²
- Hepatic steatosis (CAP ≥ 300)
- Insulin-resistant but not diabetic subjects
- Fasting plasma glucose <126 mg/dL
Key exclusion criteria (10 listed)
- Evidence of another form of liver disease
- Evidence of liver cirrhosis
- Evidence of hepatic impairment
- Positive serologic evidence of current infectious liver disease
- History of excessive alcohol intake
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 |
|---|---|---|
| PXL770Oral capsule | Drug | PXL770, Placebo |
| PlaceboOral capsule | Drug | PXL770, Placebo |
Primary outcome
PK parameters of PXL770
Time frame: Day 26
AUC : Area under the plasma concentration curve
13 secondary outcomes
Plasma PK parameters of PXL770
Time frame: Day 26
Plasma PK parameters of PXL770
Time frame: Day 26
Plasma PK parameters of PXL770
Time frame: Day 26
Plasma PK parameters of PXL770
Time frame: Day 26
Plasma PK parameters of PXL770
Time frame: Day 26
Plasma PK parameters of PXL770
Time frame: Day 26
Plasma PK parameters of PXL770
Time frame: Day 26
Plasma PK parameters of PXL770
Time frame: Day 26
Plasma PK parameters of PXL770
Time frame: Day 14 and Day 26
Plasma PK parameters of PXL770
Time frame: Day 14 and Day 26
Plasma PK parameters of PXL770
Time frame: Day 14 and Day 26
Plasma PK parameters of PXL770
Time frame: Day 27
Plasma PK parameters of PXL770
Time frame: Day 27
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 11 Jun 2021.
- Derived from this study: PubMed 35028615Fouqueray P, Bolze S, Dubourg J, Hallakou-Bozec S, Theurey P, Grouin JM, Chevalier C, Gluais-Dagorn P, Moller DE, Cusi K. Pharmacodynamic effects of direct AMP kinase activation in humans with insulin resistance and non-alcoholic fatty liver disease: A phase 1b study. Cell Rep Med. 2021 Dec 21;2(12):100474. doi: 10.1016/j.xcrm.2021.100474. eCollection 2021 Dec 21.
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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 Nonalcoholic Fatty Liver, run by Poxel SA at 1 site in United States.
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 8 inclusion and 10 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 11 Jun 2021. 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 States. 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. Some participants in this study may receive a placebo. 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?
PK parameters of PXL770 (time frame: Day 26). 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 NCT03950882, which also lists 1 linked publication.
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 11 Jun 2021.