NCT03395470

Brief 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. In Part B, we'll co-administer PXL770 and rosuvastatin (a HMG-CoA reductase inhibitor) to assess any drug-drug interaction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2018

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

November 6, 2017

Last Update Submit

August 23, 2018

Conditions

Metabolic Disease

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    From baseline to day 14

Secondary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    From baseline to day 14

Study Arms (6)

Group A1

EXPERIMENTAL

Dose 1 or placebo

Drug: PXL770Drug: Placebo

Group A2

EXPERIMENTAL

Dose 2 or placebo

Drug: PXL770Drug: Placebo

Group A3

EXPERIMENTAL

Dose 3 or placebo

Drug: PXL770Drug: Placebo

Group A4

EXPERIMENTAL

Dose 4 or placebo

Drug: PXL770Drug: Placebo

Group A5

EXPERIMENTAL

Dose 5 or placebo

Drug: PXL770Drug: Placebo

Group B

EXPERIMENTAL

Dose + Rosuvastatin

Drug: PXL770Drug: Rosuvastatin

Interventions

PXL770DRUG

MAD

Group A1Group A2Group A3Group A4Group A5Group B
PlaceboDRUG

MAD

Group A1Group A2Group A3Group A4Group A5
RosuvastatinDRUG

DDI

Group B

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammersmith Medicines Research (HMR)

London, United Kingdom

Location

MeSH Terms

Conditions

Metabolic Diseases

Interventions

2-chloro-3-(1-hydroxy-5,6,7,8-tetrahydronaphthalen-2-yl)-6-oxo-5-phenyl-7H-thieno)(2,3-b)pyridin-4-olate potassiumRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2017

First Posted

January 10, 2018

Study Start

August 21, 2017

Primary Completion

March 16, 2018

Study Completion

March 16, 2018

Last Updated

August 24, 2018

Record last verified: 2018-08

Locations

GB(1)