Table 6.
Laboratory blood parameters (PCSA definition) | Normal range | Multiple Dose Study | ||||
---|---|---|---|---|---|---|
Placebo | Ferroquine | |||||
(N = 7) | 400 mg (N = 6) | 600 mg (N = 6) | 800 mg (N = 6) | 1000 mg (N = 1) | ||
Eosinophils (> max (0.5 Giga/L, ULN)) | 0-1320/μl | 4 | 2 | 4 | 4 | 1 |
Haemoglobin (decrease≥ 2 g/dL versus baseline) | 10.0-16.5 g/dL | 0 | 0 | 0 | 0 | 0 |
Neutrophils (<1.0 Giga/L, Black) | 1400-8140/μL | 0 | 3 | 0 | 2 | 0 |
Platelets (<100 Giga/L) | 120-400 Giga/L | 1 | 1 | 2 | 0 | 0 |
White Blood Cells (<2 Giga/L, Black) | 3.5-11/μL | 0 | 1 | 0 | 0 | 0 |
ALT (normal <45UI, PCSA >2 ULN) | < 45 U/L | 1 | 1 | 2 | 1 | 0 |
AST (normal <45UI, PCSA >2 ULN) | < 45 U/L | 1 | 1 | 0 | 1 | 0 |
Alkaline phosphatase (>1.5 ULN) | 13 - 100 U/L | 0 | 1 | 0 | 1 | 0 |
CPK (≥ 3 ULN) | 25-90 U/L | 3 | 4 | 5 | 5 | 1 |
Creatinine (≥ 150 μmol/L, adults) | <133 μmol/L | 0 | 1 | 0 | 0 | 0 |
Gamma GT (≥ 3 ULN) | <50 U/L | 0 | 1 | 0 | 1 | 0 |
Glucose (≤ 2.5 mmol/L) | 3.6-6.1 mmol/L | 0 | 0 | 0 | 0 | 0 |
Glucose (≥ 2 mmol/L, fasted) | 3.6-6.1 mmol/L | 0 | 0 | 0 | 0 | 0 |
Potassium (< 3 mmol/L) | 3.5-5.0 mmol/L | 0 | 0 | 0 | 0 | 0 |
Potassium (≥ 5.5 mmol/L) | 3.5-5.0 mmol/L | 2 | 0 | 2 | 0 | 0 |
Total bilirubin (≥ 34 μmol/L) | 0-17 μmol/L | 1 | 1 | 0 | 0 | 0 |
Total cholesterol (≥ 7.74 mmol/L) | 120-240 mg/dL | 0 | 0 | 0 | 0 | 0 |
Triglycerides (≥ 4.6 mmol/L) | 0-200 mg/dL | 0 | 0 | 0 | 0 | 0 |
NOTE: N: count of patients; PCSA: Potentially Clinically Significant Abnormality (version 2.2, December 2004); LLN/ULN: Lower/Upper Limit of Normality. For hemoglobin, baseline values <LLN or >ULN are counted normal; for eosinophils, values <LLN are counted as normal. For ALT, AST, ALP, Total Bilirubin, GGT, CPK, baseline values <LLN are counted normal