Effect of Cimetidine on the PK of Imeglimin

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03618316
• Other study ID #: PXL008-023
• Status: Completed
• Phase: Phase 1
• Start date: June 19, 2018
• Est. completion date: July 27, 2018

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 27, 2018
• Est. primary completion date: July 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Imeglimin
2 singles oral doses of imeglimin 1,500 mg (one at day 1 and one at day 8)
• Cimetidine
400 mg of cimetidine bid from Day 5 to Day 10

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	Cmax: peak plasma concentration after dosing	At Day 1
Secondary	PK parameters of imeglimin	AUC last:area under the concentration-time curve	From day 1 to day 3
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Incidence of Treatment-Emergent Adverse Events	from day 1 to day 17