Safety, Tolerability and Pharmacokinetics of Tafenoquine After Weekly and Escalating Monthly Doses of Tafenoquine in Healthy Vietnamese Volunteers (TQ Study)
Project Purpose:
Primary Objective: In a dose-escalating study in the same healthy subjects compare the frequency of treatment-related safety and adverse events (AEs) after weekly 200 mg tafenoquine and two monthly (600 mg and 800 mg) tafenoquine regimens.
Vysnova’s Work:
Vysnova has collaborated with 108 Military Central Hospital, Australian Defence Force Malaria and Infectious Disease Institute (ADFMIDI), and Naval Medical Research Unit. No. TWO (NAMRU-2) to conduct this study. In 2018, the U.S. Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA) approved tafenoquine (under the brand name Arakoda™) for malaria prevention. The approved tafenoquine prophylactic regimen is 600 mg loading dose (200 mg daily for 3 days) prior to travel and a weekly 200 mg maintenance dose commencing 7 days after the last loading dose. The aim of this study is to determine whether the safety and tolerability profiles in healthy subjects taking monthly doses of 600 mg or 800 mg tafenoquine are comparable in the same subjects taking weekly 200 mg tafenoquine.
Vysnova’s Support:
- Procurement of supplies, travel, and personnel such as an SME and field workers to conduct the study at MH108 in Vietnam.
- Support of the lab analysis of Measurement of biochemical, hematological, serological, and urinalysis; Measurements of blood/plasma tafenoquine concentrations; Ex vivo antimalarial assessment of tafenoquine.
- Provision of expertise in laboratory and data to conduct the analysis of samples.
- Coordination of partners such as ADMIFI, MH108, and the Navy to ensure smooth planning and implementation of the study.
- Support of manuscript drafting and publication.
