Clinical Trial: G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief Summary:
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).
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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 ]
Original Secondary Outcome: Same as current
Information By: GlaxoSmithKline
Dates:
Date Received: March 18, 2010
Date Started: July 2009
Date Completion:
Last Updated: November 7, 2013
Last Verified: November 2013
