Safety, Tolerability and PK of PXL770 in Healthy Male Subjects

Metabolic Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395470
• Other study ID #: PXL770-002
• Status: Completed
• Phase: Phase 1
• Start date: August 21, 2017
• Est. completion date: March 16, 2018

Study information

• Verified date: August 2018
• Source: Poxel SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 16, 2018
• Est. primary completion date: March 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases

Intervention

Drug:
• PXL770
MAD
• Placebo
MAD
• Rosuvastatin
DDI

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research (HMR)	London

Sponsors (1)

Lead Sponsor	Collaborator
Poxel SA

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Part A: PK parameters of PXL770 after repeated doses	- AUC0-8: area under the concentration-time curve from 0 extrapolated to infinite	From baseline to day 14
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Incidence of treatment emergent adverse events	From baseline to day 14