drugset / Trial / NCT05203744
Escalating Monthly Doses of Tafenoquine in Healthy Volunteers
Phase 4
Unknown
200 enrolled
Naval Medical Research Center
Australian Defence Force Malaria and Infectious Disease Institute (ADF MIDI) · collabNaval Environmental Preventive Medicine Unit TWO (NEPMU-2) · collabNaval Medical Research Unit TWO (NAMRU-2) · collabThe 108 Military Central Hospital · collab
Non-randomizedSequentialOpen-labelPrevention
Summary
In 2018, the U.S. Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA) approved tafenoquine 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. This weekly tafenoquine regimen is more convenient with potentially improved compliance than daily doxycycline or atovaquone proguanil (Malarone), the other recommended prophylactic agents by the U.S. Centers for Disease Control and Prevention (CDC) for the prevention of malaria infections. Current assumptions are that a systemic minimum inhibitory concentration (MIC) of tafenoquine in plasma is 80 ng/mL in nonimmune individuals is required to prevent symptomatic breakthroughs of malaria infections. Because of tafenoquine's lengthy blood elimination half-life of 2-3 weeks, a monthly regimen of 600 mg and 800 mg of tafenoquine in individuals weighing 60 kg and 80 kg, respectively, have pharmacokinetic (PK) profiles (i.e., drug concentration versus time curves) of achieving MIC values of at least 80 ng/mL in the majority of healthy individuals. The aim of this study is to determine whether the safety and tolerability profiles in healthy participants taking monthly doses of 600 mg or 800 mg tafenoquine are comparable in the same participants taking weekly 200 mg tafenoquine. Study Hypothesis: The study hypothesis is that the frequency of tafenoquine-related safety (e.g. blood chemistries) and adverse events (AEs) in healthy participants who take a higher dose (600 mg and 800 mg) of tafenoquine monthly would be comparable to the frequency of treatment related safety and AEs in the same individuals who take weekly tafenoquine (200 mg).
Timeline
- Start
- 2022-05-10
- Primary completion
- 2022-12-03
- Completion
- 2022-12-03
Publications
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tafenoquine | Small molecule | 200 mg | Oral |
| Subject | Tafenoquine | Small molecule | 600 mg | Oral |
| Subject | Tafenoquine | Small molecule | 800 mg | Oral |
Indications
No indication recorded.