Activity of G6PD enzyme in healthy male volunteers
Conditions
Interventions
Experimental group with 36 heathy male volunteers for analysis of two collecting blood samples to complete blood count and enzyme G6PD activity to be used in studies with tafenoquina
Other
E01.370.225.998.110
Sponsors
Fundação de Medicina Tropical do Amazonas
Medicines for Malaria Venture
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: The subject is between 18 and 45 years of age, male; Hgb concentration greater or equal than 12g/dL; Reticulocyte count less or equal than 2.5%; A signed and dated informed consent from the subject or the subject’s legal representative prior to screening
Exclusion criteria
Exclusion criteria: History of haemoglobinopathy; Past or current history of methaemoglobinaemia or methaemoglobin percentage above 3%; Past medical history of G6PD deficiency; Any other co-morbidity or treatment that, in the opinion of the investigator might influence haematopoiesis; Any person that may have donated blood in the last 56 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establish the median, mean and standard deviation of G6PD enzyme activity in male subjects with normal G6PD in laboratories to be used in studies with tafenoquine;The primary population analysis showed that enzymatic activity ranged from 4.21 paragraph 8.14 UI/gHB with media SD(Standard Deviation) of 1.07 UI/GHB; 95% average; Enzymatic activity average 6.26 UI/gHB | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine the intra-laboratory coefficient of variation of quantitative assay of G6PD enzyme;The population analysis showed that variability between tests was low (CV of 4.77%) | — |
Countries
Bangladesh, Brazil, Cambodia, Colombia, Ethiopia, India, Peru, Philippines, Thailand, Viet Nam
Contacts
Public ContactServiço de Atendimento ao Cliente SAC
GlaxoSmithKline Brasil
Outcome results
None listed