A phase 2a, randomised, double-blind, placebo-controlled, cross-over, single and multiple dose study to assess the effects of imeglimin on nicotine-induced endothelial dysfunction in young non-smoker healthy male subjects.
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 19.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2016-003215-35-DE
- Lead Sponsor
- Poxel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 18
1. Signed and dated informed consent obtained before any trial-related activities.
2. Healthy male subjects, as judged by the investigator based on medical history, physical examination, vital signs, ECG and biological parameters.
3. Caucasian.
4. Right-handedness.
5. Non-smoker for the last 15 years (defined as neither having smoked nor having used nicotine substitute products regularly or occasionally).
6. Age between 18 and 35 years, both inclusive.
7. Body Mass Index (BMI) between 18.5 and 25 kg/m^2, both inclusive.
8. Estimated glomerular filtration rate = 80 mL/min/1.73 m^2 (according to the CKD-EPI formula).
9. Agreeing to use highly effective contraceptive methods as defined by the investigator and according to local guidelines until the end of the study (after follow-up visit).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological, haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness as judged by the Investigator.
2. Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the ranges for systolic 100-140 mmHg blood pressure and/or for diastolic blood pressure greater than 90 mmHg (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial).
3. Heart rate at rest outside the range of 50-90 beats per minute.
4. History of drug-induced Torsade de Pointe or presence of a familial long QT syndrome
5. Clinically significant abnormal haematology, biochemistry or coagulation screening tests, as judged by the Investigator. In particular, elevated liver enzymes (AST, ALT or ALP > 1.5 times the upper limit of normal).
6. A positive result of the alcohol breath test or urine drug screen at the screening visit.
7. A positive cotinine urine test at the screening visit.
8. Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator.
9. Acute infection within the last 2 weeks.
10. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
11. Known hypersensitivity to any of the constituents or excipients of the study IMPs, nicotine or glycerotrinitrate or history of relevant drug and/or food allergy (anaphylactic, anaphylactoid reactions).
12. Use of any prescription or non-prescription medication (including vitamins and herbal therapies) within 14 days prior to screening visit (the occasional use of paracetamol is not prohibited if judged acceptable by the investigator).
13. Positive to the screening test for Hepatitis Bs antigen or Hepatitis C antibodies and/or a positive result to the test for HIV-1/2 antibodies or HIV-1 antigen.
14. Significant history of alcoholism or drug abuse as judged by the Investigator or consuming more than 14 units of alcohol per week (one unit of alcohol equals about 330 mL of beer, one glass of wine of 120 mL, or 40 mL spirits).
15. Blood donation or blood loss of more than 500 mL within the last 30 days to screening visit.
16. Previous participation in this trial. Participation is defined as randomised.
17. Receipt of any medicinal product in clinical development within 30 days before randomisation in this trial.
18. Insufficient ultrasound imaging quality of subject’s brachial artery for FMD analysis as assessed by a screening ultrasound measurement and judged by the Investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method