Chronic kidney disease
Conditions
Brief summary
Part 1: Pharmacokinetic parameters including observed maximal plasma concentration (Cmax), time of maximum observed plasma concentration (tmax), AUC from time zero to the last quantifiable concentration (AUC0-tlast), AUC from time zero to infinity (AUC0-∞), terminal elimination half-life (t1/2λz) and renal clearance (CLR)., Part 2: Assessment of safety parameters including type and severity of adverse events (AEs), electrocardiograms (ECGs), vital signs, clinical laboratory evaluations (serum biochemistry, haematology including reticulocytes and coagulation parameters), urinalysis (dipstick) and physical examinations.
Detailed description
Part 1: Assessment of the change from baseline in serum hepcidin. • Assessment of safety parameters including type and severity of AEs, ECGs, vital signs, physical examinations, and clinical laboratory evaluations i.e., serum biochemistry, haematology (including reticulocytes and coagulation parameters) and urinalysis (dipstick)., Part 2: Assessment of the change from baseline in serum hepcidin. Assessment of the change from baseline in haemoglobin (Hb), haematocrit (b-Ht), and reticulocyte haemoglobin (b-RetHb) in blood and serum creatinine (s-Crea). Assessment of PK parameters including Cmax, tmax, AUC0-tlast, AUC0-∞, t1/2λz, plasma accumulation ratio for Cmax and AUC, time to steady state.
Interventions
DRUGSevuparin
Sponsors
Modus Therapeutics AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Pharmacokinetic parameters including observed maximal plasma concentration (Cmax), time of maximum observed plasma concentration (tmax), AUC from time zero to the last quantifiable concentration (AUC0-tlast), AUC from time zero to infinity (AUC0-∞), terminal elimination half-life (t1/2λz) and renal clearance (CLR)., Part 2: Assessment of safety parameters including type and severity of adverse events (AEs), electrocardiograms (ECGs), vital signs, clinical laboratory evaluations (serum biochemistry, haematology including reticulocytes and coagulation parameters), urinalysis (dipstick) and physical examinations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: Assessment of the change from baseline in serum hepcidin. • Assessment of safety parameters including type and severity of AEs, ECGs, vital signs, physical examinations, and clinical laboratory evaluations i.e., serum biochemistry, haematology (including reticulocytes and coagulation parameters) and urinalysis (dipstick)., Part 2: Assessment of the change from baseline in serum hepcidin. Assessment of the change from baseline in haemoglobin (Hb), haematocrit (b-Ht), and reticulocyte haemoglobin (b-RetHb) in blood and serum creatinine (s-Crea). Assessment of PK parameters including Cmax, tmax, AUC0-tlast, AUC0-∞, t1/2λz, plasma accumulation ratio for Cmax and AUC, time to steady state. | — |
Countries
Italy
Outcome results
None listed