Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects

• Sponsor: Poxel SA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03802786
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 2
• Actual Duration (Months): 8
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Impairment	Drug: Imeglimin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 6, 2018
• Actual Primary Completion Date: Jul 3, 2019
• Actual Study Completion Date: Jul 8, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Moderate hepatic impairment Single dose of Imeglimin	Drug: Imeglimin; Single administration dose of imeglimin
Experimental: Normal hepatic function Single dose of Imeglimin	Drug: Imeglimin; Single administration dose of imeglimin

Outcome Measures

Primary Outcome Measures

1. PK parameters of imeglimin [At Day 1]

   Cmax: peak plasma concentration after dosing

Secondary Outcome Measures

1. PK parameters of imeglimin [From day 1 to day 2]

   AUC last:area under the concentration-time curve

2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [From day 1 to day 7]

   Incidence of Treatment-Emergent Adverse Events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Participation in other clinical trials of unlicensed or prescription medicines

Exclusion criteria for healthy volunteer

• Positive test for HBV, HBC

• eGFR less than 90 mL/min/1.73 m2

• liver diseases

Exclusion criteria for hepatic impaired

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Apex	Munich		Germany

Sponsors and Collaborators

• Poxel SA

Investigators

• Study Director: Clémence Chevalier, Poxel SA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poxel SA
• ClinicalTrials.gov Identifier: NCT03802786
• Other Study ID Numbers: PXL008-024
• First Posted: Jan 14, 2019
• Last Update Posted: Aug 11, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Poxel SA: pharmacokinetics
• Additional relevant MeSH terms: Liver Diseases

Study Results

No Results Posted as of Aug 11, 2020