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Safety, Tolerability and PK of PXL770 in Healthy Male Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395470
Recruitment Status : Completed
First Posted : January 10, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Poxel SA

Tracking Information
First Submitted Date  ICMJE November 6, 2017
First Posted Date  ICMJE January 10, 2018
Last Update Posted Date August 24, 2018
Actual Study Start Date  ICMJE August 21, 2017
Actual Primary Completion Date March 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2018)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2018)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: From baseline to day 14 ]
Incidence of treatment emergent adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and PK of PXL770 in Healthy Male Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Disease
Intervention  ICMJE
  • Drug: PXL770
    MAD
  • Drug: Placebo
    MAD
  • Drug: Rosuvastatin
    DDI
Study Arms  ICMJE
  • Experimental: Group A1
    Dose 1 or placebo
    Interventions:
    • Drug: PXL770
    • Drug: Placebo
  • Experimental: Group A2
    Dose 2 or placebo
    Interventions:
    • Drug: PXL770
    • Drug: Placebo
  • Experimental: Group A3
    Dose 3 or placebo
    Interventions:
    • Drug: PXL770
    • Drug: Placebo
  • Experimental: Group A4
    Dose 4 or placebo
    Interventions:
    • Drug: PXL770
    • Drug: Placebo
  • Experimental: Group A5
    Dose 5 or placebo
    Interventions:
    • Drug: PXL770
    • Drug: Placebo
  • Experimental: Group B
    Dose + Rosuvastatin
    Interventions:
    • Drug: PXL770
    • Drug: Rosuvastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2018)
60
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2018)
52
Actual Study Completion Date  ICMJE March 16, 2018
Actual Primary Completion Date March 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03395470
Other Study ID Numbers  ICMJE PXL770-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Poxel SA
Study Sponsor  ICMJE Poxel SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Poxel SA
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP