Malaria glucose 6 phosphate dehydrogenase deficiency glucose 6 phosphate dehydrogenase deficiency Primaquine Malaria
Conditions
Interventions
Primaquine 45 mg will be prescribed orally with a light snack at baseline (Day 0)
Experimental Drug
Sponsors
University of Oxford
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male aged between the age of 18 and 65 years 2. Hb more than and/or equal to 11 g/dL 3. Healthy as judged by the history taking and examining physician 4. Written informed consent provided by the volunteer. Witnessed consent is required, if the individual cannot read or write.
Exclusion criteria
Exclusion criteria: 1. Known to have any clinically significant disease or to have a clinically significant disease or disorder at this screening time 2. Received a blood transfusion in the past 3 months 3. Donated more than 300 mL of whole blood within the previous 3 months 4. Taking or taken within the past 3 weeks any drug known to cause haemolysis in G6PD deficiency 5. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and lactate dehydrogenase (LDH) > 1.5 times the upper limit of normal (ULN) 6. A serum creatinine (Scr) above the upper limit of normal (> 1.2 mg/dL) and an eGFR < 70 mL/min/1.73 m2 * 7. Conjugated bilirubin > 1.5 x ULN 8. Unconjugated bilirubin > 1.5 x ULN 9. Methaemoglobin (MetHb) level > 5% determined by oximetry 10. Have taken part in research involving an investigational drug within the past 8 weeks. 11. Subject who is likely to be unable to follow with the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the haematological effect of a single dose of primaquine in healthy G6PD deficient hemizygous males Day 0 to Day 14 Haemoglobin concentrations and reticulocyte counts over time | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess tolerability 1 year Adverse events,Document the disposition of primaquine and carboxyprimaquine Day 0 over 24 hour Concentrations of primaquine and carboxyprimaquine ,Define the relationships between primaquine pharmacokinetics and fall in haemoglobin and rise in reticulocyte counts Day 0 to Day 14 Haemoglobin and reticulocyte profiles derived from a pharmacokinetic pharmacodynamic model,Attempt to identify primaquine's oxidative metabolites in blood and urine Day 0 to Day 14 Measure 2, 3, 4 & 5 hydroxyprimaquine and 5, 6-orthoquinone in whole blood, plasma, red cells and urine. | — |
Countries
Thailand
Contacts
Public ContactNick White
Mahidol Oxford Tropical Medicine Research unit
Outcome results
None listed