Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects
- Registration Number
- NCT03802786
- Lead Sponsor
- Poxel SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Moderate hepatic impairment Imeglimin Single dose of Imeglimin Normal hepatic function Imeglimin Single dose of Imeglimin
- Primary Outcome Measures
Name Time Method PK parameters of imeglimin At Day 1 Cmax: peak plasma concentration after dosing
- Secondary Outcome Measures
Name Time Method PK parameters of imeglimin From day 1 to day 2 AUC last:area under the concentration-time curve
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] From day 1 to day 7 Incidence of Treatment-Emergent Adverse Events
Trial Locations
- Locations (1)
Apex
🇩🇪Munich, Germany