Hepatic ImpairmentPhase 1NCT03802786
Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects
A Phase 1 study testing Imeglimin in people with Hepatic Impairment, run by Poxel SA at 1 site in Germany.
Trial summary
This is a Phase 1, single-centre, open-label, parallel-group study in subjects with moderate hepatic impairment and subjects with normal hepatic function. Child-Pugh (CP) scoring will be used to determine hepatic impairment. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Imeglimin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- 6 Nov 2018to 8 Jul 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian
- BMI :18.0 and 40.0 kg/m2 and weight ≥50 kg.
- Stable hepatic impairment or normal hepatic function for healthy volunteer
- No clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (Subjects with moderate hepatic impairment may have medical findings consistent with their hepatic dysfunction)
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception
- Informed consent signature
Who cannot join
- Clinically relevant abnormal findings at the screening assessment
- Severe adverse reaction to any drug or sensitivity to the trial medication or its componentsClinically significant vital signs outside the acceptable range at screening
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- Drug or alcohol abuse
- Positive test HIV
- Smoking more than 10 cig/day
Show all 16Show fewer
- Participation in other clinical trials of unlicensed or prescription medicines
- Positive test for HBV, HBC
- eGFR less than 90 mL/min/1.73 m2
- liver diseases
- eGFR less than 80 mL/min/1.73 m2
- Hepatic impairment due to non liver disease
- History of hepatocellular carcinoma or acute liver disease
- CLinically significant change in liver disease status within 6 months
- ascites
- encephalopathy grade III or IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of Imeglimin in Subjects With Moderate Hepatic Impairment Compared to Matched Healthy Control Subjects
This is a Phase 1, single-centre, open-label, parallel-group study in subjects with moderate hepatic impairment and subjects with normal hepatic function. Child-Pugh (CP) scoring will be used to determine hepatic impairment.
- Conditions
- Hepatic Impairment
- Being tested
- Imeglimin
- Keywords
- pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImegliminDrug
Single administration dose of imeglimin
| Study group | Role | What they receive |
|---|---|---|
| Moderate hepatic impairment | Experimental | Single dose of Imeglimin Receives: Drug: Imeglimin |
| Normal hepatic function | Experimental | Single dose of Imeglimin Receives: Drug: Imeglimin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters of imeglimin
Cmax: peak plasma concentration after dosing
Measured: At Day 1
Secondary outcomes (2)
PK parameters of imeglimin
AUC last:area under the concentration-time curve
Measured: From day 1 to day 2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events
Measured: From day 1 to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start6 Nov 2018
- Primary completion3 Jul 2019
- Study completion8 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poxel SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clémence Chevalier, Study director, Poxel SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802786
- Sponsor's protocol ID
- PXL008-024
- Status last verified
- Aug 2020
- First submitted
- 10 Jan 2019
- Last updated
- 11 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of Imeglimin in Subjects With Moderate Hepatic Impairment Compared to Matched Healthy Control Subjects
- ClinicalTrials.gov ID
- NCT03802786
- Acronym / sponsor ID
- PXL008-024
- Conditions
- Hepatic Impairment
- Keywords
- pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Poxel SAIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 8 Jul 2019 (actual)
- First posted
- 14 Jan 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 is a Phase 1, single-centre, open-label, parallel-group study in subjects with moderate hepatic impairment and subjects with normal hepatic function. Child-Pugh (CP) scoring will be used to determine hepatic impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate hepatic impairment | Experimental | Drug: ImegliminSingle dose of Imeglimin |
| Normal hepatic function | Experimental | Drug: ImegliminSingle dose of Imeglimin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Caucasian
- BMI :18.0 and 40.0 kg/m2 and weight ≥50 kg.
- Stable hepatic impairment or normal hepatic function for healthy volunteer
- No clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (Subjects with moderate hepatic impairment may have medical findings consistent with their hepatic dysfunction)
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception
Key exclusion criteria (16 listed)
- Clinically relevant abnormal findings at the screening assessment
- Severe adverse reaction to any drug or sensitivity to the trial medication or its componentsClinically significant vital signs outside the acceptable range at screening
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- Drug or alcohol abuse
- Positive test HIV
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 |
|---|---|---|
| ImegliminSingle administration dose of imeglimin | Drug | Moderate hepatic impairment, Normal hepatic function |
Primary outcome
PK parameters of imeglimin
Time frame: At Day 1
Cmax: peak plasma concentration after dosing
2 secondary outcomes
PK parameters of imeglimin
Time frame: From day 1 to day 2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From day 1 to day 7
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 Aug 2020.
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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.
Clémence Chevalier study director
Poxel SA
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 Imeglimin in people with Hepatic Impairment, run by Poxel SA at 1 site in Germany.
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 6 inclusion and 16 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 Aug 2020. 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 Germany. 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?
PK parameters of imeglimin (time frame: At Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2020.