Effect of Cimetidine on the PK of Imeglimin

An Open-label, One-sequence Study to Assess the Effect of Repeated Oral Doses of Cimetidine on the Single Dose Pharmacokinetics, Safety and Tolerability of Imeglimin in Healthy Caucasian Subjects

The trial is an open-label assessment of the interaction of imeglimin with cimetidine. Up to 16 healthy men and women will receive a single oral dose of 1,500 mg imeglimin alone followed by a second dose of imeglimin during repeated doses of 400 mg cimetidine taken twice daily for 6 days.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Imeglimin; Drug: Cimetidine

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Hammersmith Medicines Research (HMR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI : 18.5-29.9
• Body weight ≥ 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open-label imeglimin + cimetidine; Day 1: single oral dose of 1,500 mg imeglimin Day 5 to Day 10 inclusive: repeated doses of 400 mg cimetidine twice daily Day 8: second 1,500 mg dose of imeglimin together with the morning dose of cimetidine	Drug: Imeglimin; 2 singles oral doses of imeglimin 1,500 mg (one at day 1 and one at day 8); Drug: Cimetidine; 400 mg of cimetidine bid from Day 5 to Day 10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters of imeglimin	Cmax: peak plasma concentration after dosing	At Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters of imeglimin	AUC last:area under the concentration-time curve	From day 1 to day 3
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Incidence of Treatment-Emergent Adverse Events	from day 1 to day 17

Collaborators and Investigators

• Sponsor: Poxel SA

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2018
• Primary Completion (Actual): July 21, 2018
• Study Completion (Actual): July 27, 2018

Study Registration Dates

• First Submitted: June 8, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 7, 2018

Study Record Updates

• Last Update Posted (Actual): August 27, 2018
• Last Update Submitted That Met QC Criteria: August 23, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: pharmacokinetics; Drug-drug interaction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Cytochrome P-450 Enzyme Inhibitors; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Cytochrome P-450 CYP1A2 Inhibitors; Histamine H2 Antagonists; Cimetidine
• Other Study ID Numbers: PXL008-023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No