Malaria, Vivax Clinical Trial
Official title:
A Five-cohort, Randomized, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics of a Single Dose of Tafenoquine (SB252263) 300mg When Co-administered With the Artemisinin-based Combination Therapies (ACT) Artemether + Lumefantrine (AL) and Dihydroartemisinin + Piperaquine Tetraphosphate (DHA+PQP)
This will be a single-centre, 5-cohort, randomized open-label, parallel-group study in
healthy volunteer subjects. This study aims to provide sufficient pharmacokinetic (PK)
evidence to support the safe usage of Tafenoquine (TQ) in studies and markets where the
Artemisinin-based Combination Therapies (ACTs) are the standard of care for patients with
Plasmodium vivax malaria (i.e., co administration with TQ). The objective of this study is to
assess the pharmacokinetics, safety and tolerability of TQ when co-administered with the
chosen ACTs (AL and DHA + PQP), administered concomitantly in healthy subjects. Specifically,
the study will evaluate whether there are drug-drug interactions between TQ and each of the
ACTs and if these interactions are considered to be clinically significant. The co-primary
objectives of this study are to characterize both the effects of a 300 milligram (mg) single
dose of TQ on the pharmacokinetics; changes in (area under the concentration-time curve from
0 to time t) AUC (0-t), AUC (0-infinity), and maximum observed concentration (Cmax) of each
of the two Artemisinin-based Combination Therapies (ACT) according to their prescribed dose
when co-administered as well as the effects of the ACTs on the PK of TQ.
A total of 120 subjects (24 subjects in each of 5 cohorts) are planned to be enrolled in
order to ensure a target sample size of at least 22 subjects completing the study per cohort.
All subjects will arrive in the unit at least 24 hours prior to dosing and be discharged
after 72-hour post first dose assessments have been completed. Subjects will return for
outpatient visits on Days 7, 14, 21, 28, and 56 after first dose.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05096702 -
Operational Feasibility of Appropriate Radical Cure of Plasmodium Vivax With Tafenoquine or Primaquine After Quantitative G6PD Testing in Brazil
|
||
| Recruiting |
NCT05540470 -
Radical CUREfor MAlaria Among Highly Mobile and Hard-to-reach Populations in the Guyanese Shield
|
N/A | |
| Active, not recruiting |
NCT04079621 -
Short Course Radical Cure of P. Vivax Malaria in Nepal
|
Phase 4 | |
| Completed |
NCT03307369 -
A Retrospective Study of Severe Plasmodium Vivax
|
||
| Completed |
NCT01213966 -
Efficacy, Tolerability, PK of OZ439 in Adults With Acute, Uncomplicated P.Falciparum or Vivax Malaria Mono-infection
|
Phase 2 | |
| Completed |
NCT00811096 -
Pilot Human Study of Tinidazole Efficacy For Radical Cure Of Plasmodium Vivax
|
Phase 2 | |
| Terminated |
NCT03337152 -
Assessing a Risk Model for G6PD Deficiency
|
Phase 4 | |
| Completed |
NCT05753150 -
Operational Feasibility of Appropriate Plasmodium Vivax Radical Cure After G6PD Testing in Thailand
|
||
| Completed |
NCT02751294 -
A Study to Assess the Effects of Dissolution Profile on the Pharmacokinetics of Single Oral Doses of Tafenoquine Tablets and Tafenoquine Stable Isotope Labelled Solution
|
Phase 1 | |
| Recruiting |
NCT05058885 -
Plasmodium Vivax Among Duffy Negative Population in Cameroon.
|
||
| Completed |
NCT03377296 -
Study of Controlled Human Plasmodium Vivax Infection
|
N/A | |
| Completed |
NCT00486694 -
Artesunate Plus Sulfadoxine-Pyrimethamine Versus Chloroquine for Vivax Malaria
|
Phase 2 | |
| Recruiting |
NCT05788094 -
ACT vs CQ With Tafenoquine for P. Vivax Mono-infection
|
Phase 4 | |
| Terminated |
NCT02110784 -
Eurartesim® in Patients With Imported Uncomplicated Plasmodium Vivax Malaria
|
Phase 2 | |
| Not yet recruiting |
NCT05690841 -
FocaL Mass Drug Administration for Vivax Malaria Elimination
|
Phase 3 | |
| Not yet recruiting |
NCT04739917 -
Efficacy of a Synthetic Vaccine Derived From Plasmodium Vivax Circumsporozoite Protein (PvCS) in naïve and Semi-immune Volunteers
|
Phase 2 | |
| Completed |
NCT03208907 -
DHA-PQP vs Chloroquine and Primaquine for Radical Cure of Vivax Malaria in Brazil
|
Phase 3 | |
| Completed |
NCT01928914 -
Tafenoquine Thorough QTc Study in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT00157885 -
A Randomised Trial of Artekin and Artesunate & Amodiaquine for Uncomplicated Malaria in Timika, Papua, Indonesia.
|
N/A | |
| Completed |
NCT01081847 -
Safety and Immunogenicity Study of Plasmodium Vivax CS Derived Synthetic Peptides Formulated in Two Adjuvants
|
Phase 1 |