Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04744636 | Vascular Function and Biomarker Assessments in Healthy Volunteers and in Patients With Type 2 Diabetes Mellitus | PHASE1 | COMPLETED | 100 | — | — | Apr 3, 2017 | Sep 15, 2018 | Jul 25, 2024 | 1 | Germany |
Plasma/platelet levels of Dihydrobiopterin (BAH)/Tetrahydrobiopterin (BH4), Cyclic guanosine monophosphate (cGMP)
| Arm | Type | Description |
|---|---|---|
| Healthy volunteers aged of 18-30 years | OTHER | - |
| Healthy volunteers aged of 50-59 years | OTHER | - |
| Healthy volunteers aged of 60-70 years | OTHER | - |
| Type 2 diabetic patients aged of 50-70 years | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Other | DRUG | Healthy volunteers will be selected within 3 weeks before inclusion (Day 0). The investigations will be performed on 2 days (Day 1 (D1) and Day 2 (D2)): vascular endothelial function assessment and blood collection for biomarker investigation on Day 1 and Case Report Form (CFR) on Day 2. Then, subjects will be discharged at the end of the last investigation day (Day 2). All the participants have received two pharmacological agents (NIMP) : * Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function. * Adenosine : administered intravenously during MRI for the measurement of CFR. |
Inclusion Criteria: Healthy volunteers: * Age \[18 -30\], \[50-59\] and \[60-70\] years * Male and female healthy volunteers, except with skin types 5 and 6 * Body weight ≥ 50 kg and BMI between \[18.0 -28.0\] kg/m\^2 inclusive * Non or ex-smokers (defined as someone who completely stopped smoking...