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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03618316

Enrollment

Registered

2018-08-07

Start date

2018-06-19

Completion date

2018-07-27

Last updated

2018-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

pharmacokinetics, Drug-drug interaction

Brief 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.

Interventions

DRUGImeglimin

2 singles oral doses of imeglimin 1,500 mg (one at day 1 and one at day 8)

DRUGCimetidine

400 mg of cimetidine bid from Day 5 to Day 10

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026