Safety, Tolerability and PK of Imeglimin in Japanese Volunteers

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase 1, Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Imeglimin in Healthy Japanese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373150
• Other study ID #: PXL008-011
• Status: Completed
• Phase: Phase 1
• First received: February 2, 2015
• Last updated: February 9, 2017
• Start date: February 2015
• Est. completion date: October 2015

Study information

• Verified date: February 2017
• Source: Poxel SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the pharmacokinetics of single and repeated doses of imeglimin in healthy Japanese subjects, and the safety and tolerability of single and repeated doses of imeglimin in healthy Japanese subjects.

Description:

Combined single and repeated dose groups with 3 escalating doses

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Male or female Japanese 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 18.0-25.0 kg/m2

• 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

• Use of vitamins, herbal medicines, or over-the-counter medication (with the exception of paracetamol [acetaminophen]) within 7 days before first dose of trial medication, or prescribed medication during the 14 days before first dose of trial medication

• 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

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Imeglimin

• Placebo

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	PK parameters of imeglimin after single and repeated doses: - Cmax: peak plasma concentration after dosing, AUC0-8: area under the concentration-time curve from 0 extrapolated to infinite time, - Tmax: time of peak plasma concentration of imeglimin	Cmax: peak plasma concentration after dosing; AUC0-8: area under the concentration-time curve from 0 extrapolated to infinite time; AUC0-t: area under the concentration-time curve from 0 to the time of last quantifiable concentration; Tmax: time of peak plasma concentration of imeglimin	From baseline to Day 13
Primary	Safety and tolerability of imeglimin: laboratory assessments	routine hematology, biochemistry, coagulation and urinalysis; physical examination; 12-lead ECG; vital signs; capillary glucose; incidence of adverse events	From baseline to Day 13