G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine)
SB-252263 (Tafenoquine, TQ) is an 8-aminoquinoline (8-AQ) antimalarial drug being developed by GlaxoSmithKline (GSK), the U.S. Army Medical Research and Materiel Command (USAMRMC) and Medicines for Malaria Venture (MMV). TQ is currently being developed for the radical cure of acute P. vivax malaria in combination with standard doses of CQ, which is 1500 mg over 3 days.
The current gold standard for radical cure of P. vivax malaria in many areas of the world is chloroquine (CQ) for clearance of the acute parasitemia immediately followed by primaquine (PQ) to clear the liver stages of the parasite and prevent disease relapse. The 8-AQ class of drugs, including PQ, is hemolytic in subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency. The current study will identify a dose of TQ within the target efficacious dose range that has a hemolytic effect similar to or less than PQ 15 mg OD x 14 days (i.e. ≤ 25-30% hemoglobin decline in WHO class III G6PD-deficient subjects).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||A Phase I Study to Investigate the Hemolytic Potential of Tafenoquine in Healthy Subjects With Glucose-6-phosphate Dehydrogenase Deficiency and the Safety and Tolerability of Tafenoquine in Acute Plasmodium Vivax Malaria Patients With Glucose-6-phosphate Dehydrogenase Deficiency|
- To evaluate the safety, tolerability, and hemolytic potential of TQ in G6PD-deficient female healthy volunteers compared with G6PD-normal female healthy volunteers. This will be done by measuring maximum absolute decline in Haemoglobin from baseline [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Maximum absolute decline in Hgb (or Hct) from baseline for TQ in G6PD-deficient healthy volunteers compared to G6PD-normal healthy volunteers. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Tafenoquine
Tafenoquine, TQ is an 8-aminoquinoline (8-AQ) antimalarial drug being developed for the radical cure of acute P. vivax malaria. Chloroquine will be given for the first 3 days in second and third part of this study to treat Malaria.
The current gold standard for radical cure of P. vivax malaria in many areas of the world is chloroquine (CQ); typically 600 mg day 1, 600 mg day 2, 300 mg day 3 for clearance of the acute parasitemia. After this Tafenoquine will be given and subject will be followed up.Drug: Tafenoquine
Once daily on Day 1 only. For Part B and C of this study Chloroquine will be given to treat Malaria
Active Comparator: Chloroquine
Dose for first 3 days for Part B & C of the study
The current gold standard for radical cure of P. vivax malaria in many areas of the world is chloroquine (CQ); typically 600 mg day 1, 600 mg day 2, 300 mg day 3 for clearance of the acute parasitemia. After this Tafenoquine will be given and subject will be followed up.
Active Comparator: Primaquine
once daily for first 14 days
Primaquine (PQ) is another 8 aminoquinoline drug available for Malaria treatment
|GSK Investigational Site|
|Bangkok, Thailand, 10700|
|GSK Investigational Site|
|Tak, Thailand, 63110|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|