bilirubin, bilirubine, hart- en vaatziekten, cardiovascular disease
Conditions
Interventions
Increasing amounts of bilirubin will be administered both intra-arterially (first phase - low total dose) and intravenously (second phase - high total dose). Dose levels will remain far below those le
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Inclusion criteria
Inclusion criteria: At least 18 and not older than 65 years of age.
Exclusion criteria
Exclusion criteria: 1. Cocumented history of sensitivity or indiosyncrasy to medicinal products or excipients; 2. History of or current abuse of drugs, alcohol or solvents; 3. Use of any medication except for anti-conceptives; 4. Sexually active women in reproductive age group without appropriate anti-conceptive therapy; 5. Any (sign of) active disease; 6. History of liver disease; 7. Laboratory results exceeding twice the upper limit of normal range; 8. Total bilirubin level of 10 micromol/L or higher, suggesting the presence of the Gilbert syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bilirubin concentrations attained after parenteral administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety parameters including for example body temperature, heart rate and blood pressure. | — |
Contacts
Public ContactDouwe Dekker
PO box 9101
Outcome results
None listed