Metabolic DiseasePhase 1NCT03395470
Safety, Tolerability and PK of PXL770 in Healthy Male Subjects
A Phase 1 study testing PXL770 and Rosuvastatin in people with Metabolic Disease, run by Poxel SA at 1 site in United Kingdom.
Trial summary
PXL770 is a direct activator of 5' adenosine monophosphate-activated protein kinase (AMPK) being developed by Poxel S.A. for the treatment of type 2 diabetes mellitus (T2DM). In Part A of this study, we'll test the safety, tolerability and pharmacokinetics (PK) of repeated doses. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease
- What is being tested?
- PXL770 and Rosuvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Aug 2017to 16 Mar 2018
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
- body mass index in the range 18.5-29.9 kg/m²
- body weight at least 60 kg
- willing to use reliable contraception
- able to give fully informed written consent.
Who cannot join
- Pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception
- Clinically relevant abnormal findings at the screening assessment
- Clinically significant vital signs outside the acceptable range at screening
- Clinically relevant abnormal medical history, surgery or concurrent medical condition
- Acute or chronic illness
- Estimated glomerular filtration rate less than 80 mL/min/1.73 m2
Show all 14Show fewer
- Severe adverse reaction to any drug or sensitivity to the trial medication or its components
- Significant food allergy; vegetarian or vegan
- Participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 mL blood, within the 3 months before first dose of trial medication
- Drug or alcohol abuse
- Smoking of more than 5 cigarettes daily
- Possibility that subject will not cooperate
- Positive test for hepatitis B \& C, HIV
- Objection by a General Practitioner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of PXL770, Including an Open-label, One-sequence Part to Assess the Drug-drug Interaction With Rosuvastatin in Healthy Male Subjects
PXL770 is a direct activator of 5' adenosine monophosphate-activated protein kinase (AMPK) being developed by Poxel S.A. for the treatment of type 2 diabetes mellitus (T2DM). In Part A of this study, we'll test the safety, tolerability and pharmacokinetics (PK) of repeated doses. In Part B, we'll co-administer PXL770 and rosuvastatin (a HMG-CoA reductase inhibitor) to assess any drug-drug interaction.
- Conditions
- Metabolic Disease
- Being tested
- PXL770, Placebo, Rosuvastatin
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PXL770Drug
MAD
PlaceboDrug
MAD
RosuvastatinDrug
DDI
| Study group | Role | What they receive |
|---|---|---|
| Group A1 | Experimental | Dose 1 or placebo Receives: Drug: PXL770; Drug: Placebo |
| Group A2 | Experimental | Dose 2 or placebo Receives: Drug: PXL770; Drug: Placebo |
| Group A3 | Experimental | Dose 3 or placebo Receives: Drug: PXL770; Drug: Placebo |
| Group A4 | Experimental | Dose 4 or placebo Receives: Drug: PXL770; Drug: Placebo |
| Group A5 | Experimental | Dose 5 or placebo Receives: Drug: PXL770; Drug: Placebo |
| Group B | Experimental | Dose + Rosuvastatin Receives: Drug: PXL770; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: PK parameters of PXL770 after repeated doses Part B: PK parameters of rosuvastatin before and after repeated doses of PXl770
- Cmax: peak plasma concentration after dosing
Measured: From baseline to day 14
Part A: PK parameters of PXL770 after repeated doses
- AUC0-t: area under the concentration-time curve from 0 extrapolated to time t
Measured: From baseline to day 14
Part A: PK parameters of PXL770 after repeated doses
- AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite
Measured: From baseline to day 14
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of treatment emergent adverse events
Measured: From baseline to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start21 Aug 2017
- Primary completion16 Mar 2018
- Study completion16 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies 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
- 60 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
- NCT03395470
- Sponsor's protocol ID
- PXL770-002
- Status last verified
- Aug 2018
- First submitted
- 6 Nov 2017
- Last updated
- 24 Aug 2018
- 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 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of PXL770, Including an Open-label, One-sequence Part to Assess the Drug-drug Interaction With Rosuvastatin in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03395470
- Acronym / sponsor ID
- PXL770-002
- Conditions
- Metabolic Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Poxel SAIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 16 Mar 2018 (actual)
- Study completion
- 16 Mar 2018 (actual)
- First posted
- 10 Jan 2018 (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.
PXL770 is a direct activator of 5' adenosine monophosphate-activated protein kinase (AMPK) being developed by Poxel S.A. for the treatment of type 2 diabetes mellitus (T2DM). In Part A of this study, we'll test the safety, tolerability and pharmacokinetics (PK) of repeated doses. In Part B, we'll co-administer PXL770 and rosuvastatin (a HMG-CoA reductase inhibitor) to assess any drug-drug interaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A1 | Experimental | Drug: PXL770, Drug: PlaceboDose 1 or placebo |
| Group A2 | Experimental | Drug: PXL770, Drug: PlaceboDose 2 or placebo |
| Group A3 | Experimental | Drug: PXL770, Drug: PlaceboDose 3 or placebo |
| Group A4 | Experimental | Drug: PXL770, Drug: PlaceboDose 4 or placebo |
| Group A5 | Experimental | Drug: PXL770, Drug: PlaceboDose 5 or placebo |
| Group B | Experimental | Drug: PXL770, Drug: RosuvastatinDose + Rosuvastatin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male subjects deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
- body mass index in the range 18.5-29.9 kg/m²
- body weight at least 60 kg
- willing to use reliable contraception
- able to give fully informed written consent.
Key exclusion criteria (14 listed)
- Pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception
- Clinically relevant abnormal findings at the screening assessment
- Clinically significant vital signs outside the acceptable range at screening
- Clinically relevant abnormal medical history, surgery or concurrent medical condition
- Acute or chronic illness
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 |
|---|---|---|
| PXL770MAD | Drug | Group A1, Group A2, Group A3, Group A4, Group A5, Group B |
| PlaceboMAD | Drug | Group A1, Group A2, Group A3, Group A4, Group A5 |
| RosuvastatinDDI | Drug | Group B |
Primary outcome
Part A: PK parameters of PXL770 after repeated doses Part B: PK parameters of rosuvastatin before and after repeated doses of PXl770
Time frame: From baseline to day 14
- Cmax: peak plasma concentration after dosing
Part A: PK parameters of PXL770 after repeated doses
Time frame: From baseline to day 14
- AUC0-t: area under the concentration-time curve from 0 extrapolated to time t
Part A: PK parameters of PXL770 after repeated doses
Time frame: From baseline to day 14
- AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From baseline to day 14
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 24 Aug 2018.
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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 and Rosuvastatin in people with Metabolic Disease, 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 5 inclusion and 14 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 24 Aug 2018. 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?
Part A: PK parameters of PXL770 after repeated doses Part B: PK parameters of rosuvastatin before and after repeated doses of PXl770 (time frame: From baseline to day 14). The study lists 3 primary outcomes in all. 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 24 Aug 2018.