Table 5.
Summary of participants with PCSA (parameters with PCSA definitions) for clinical chemistry and haematology parameters during the single dose study
| Laboratory blood parameters (PCSA definition) | Normal range | Single Dose Study | |||||
|---|---|---|---|---|---|---|---|
| Placebo | Ferroquine | ||||||
| (N = 10) | 400 mg (N = 6) | 800 mg (N = 6) | 1200 mg (N = 6) | 1400 mg (N = 6) | 1600 mg (N = 6) | ||
| Eosinophils (> max (0.5 Giga/L, ULN)) | 0-1320/μl | 6 | 5 | 1 | 3 | 6 | 5 |
| Haemoglobin (decrease≥ 2 g/dL versus baseline) | 10.0-16.5 g/dL | 1 | 0 | 4 | 1 | 0 | 0 |
| Neutrophils (<1.0 Giga/L, Black) | 1400-8140/μL | 4 | 3 | 2 | 1 | 1 | 4 |
| Platelets (<100 Giga/L) | 120-400 Giga/L | 0 | 0 | 0 | 0 | 0 | 0 |
| White Blood Cells (<2 Giga/L, Black) | 3.5-11/μL | 0 | 1 | 1 | 0 | 0 | 0 |
| ALT (PCSA >2 ULN) | < 45 U/L | 0 | 1 | 1 | 0 | 0 | 0 |
| AST (PCSA >2 ULN) | < 45 U/L | 0 | 1 | 1 | 0 | 0 | 2 |
| Alkaline phosphatase (>1.5 ULN) | 13 - 100 U/L | 0 | 0 | 1 | 0 | 0 | 0 |
| CPK (≥ 3 ULN) | 25-90 U/L | 1 | 0 | 2 | 2 | 1 | 1 |
| Creatinine (≥ 150 μmol/L, adults) | <133 μmol/L | 1 | 0 | 1 | 0 | 0 | 1 |
| Gamma GT (≥ 3 ULN) | <50 U/L | 0 | 0 | 1 | 0 | 0 | 0 |
| Glucose (≤ 2.5 mmol/L) | 3.6-6.1 mmol/L | 0 | 0 | 0 | 0 | 1 | 1 |
| Glucose (≥ 2 mmol/L, fasted) | 3.6-6.1 mmol/L | 1 | 0 | 0 | 0 | 0 | 0 |
| Potassium (< 3 mmol/L) | 3.5-5.0 mmol/L | 0 | 1 | 0 | 0 | 0 | 0 |
| Potassium (≥ 5.5 mmol/L) | 3.5-5.0 mmol/L | 0 | 0 | 0 | 0 | 1 | 1 |
| Total bilirubin (≥ 34 μmol/L) | 0-17 μmol/L | 1 | 1 | 0 | 0 | 0 | 0 |
| Total cholesterol (≥ 7.74 mmol/L) | 120-240 mg/dL | 0 | 0 | 0 | 0 | 0 | 0 |
| Triglycerides (≥ 4.6 mmol/L) | 0-200 mg/dL | 0 | 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