None listed
Conditions
Interventions
None listed
Sponsors
GlaxoSmithKline Pharmaceuticals Ltd
GlaxoSmithKline Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subject is between 18 and 45 years of age, inclusive, 2. The subject is male, 3. The subject has a Hgb concentration ≥12g/dL 4. The subject has a reticulocyte count ≤ 2.5% 5. A signed and dated informed consent is obtained from the subject or the subject?s legal representative prior to screening.
Exclusion criteria
Exclusion criteria: History of haemoglobinopathy (e.g. sickle cell disease, hereditary spherocytosis, thalassaemias, haemoglobin M/E, etc.); past or current history of methaemoglobinaemia or methaemoglobin percentage above 3% 2. Past medical history of G6PD deficiency 3. Any other co-morbidity or treatment that, in the opinion of the investigator, might influence haematopoiesis 4. Any person that may have donated blood in the last 56 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish a normal range for non G6PD deficient males in laboratories being used to screen patients in study TAF112582Timepoint: 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective is to assess the intra-laboratory variability of the G6PD quantitative enzyme assay.Timepoint: 2 months | — |
Countries
Bangladesh, Brazil, India, Peru, Thailand
Contacts
Public ContactDr Jeroze Dalal
GlaxoSmithKline Pharmaceuticals Ltd
Outcome results
None listed