NCT02742285

Lumefantrine in Venous Plasma Versus Dried Capillary Blood Spot

Comparison of Lumefantrine Concentrations Measured in Venous Plasma Versus in Dried Capillary Blood Spot Samples in Healthy Volunteers.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Thierry Buclin · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Measurement of the concentration of antimalarials in the blood of the general population helps estimating the overall drug pressure and is used in efficacy studies. The current sampling standard for drug measurement is plasma obtained by venous puncture. The use of a Dried Blood Spots (DBS) sampling strategy can make some aspects of field trials conditions easier, but concordance with usual venous sampling is not yet established. The current work will allow validating the concentrations of lumefantrine measured in the DBS samples collected during the field trials and validate the use of DBS for future studies. In addition, bearing in mind the substantial deployment of artemether-lumefantrine combinations supplies throughout most malaria endemic countries, this study may improve our understanding of lumefantrine and artemether distribution in the blood compartments and generate knowledge for further developing analytical methods for drug measurement. The overall purpose of this study is to validate the dried blood spots as a sampling method for the analysis of lumefantrine. The primary objective is to assess the concordance between lumefantrine plasma and dried blood spots (DBS) concentrations. The investigators also aim at describing lumefantrine's distribution in the different blood compartments: binding to plasma proteins, total in plasma, inside the red blood cells, total in whole blood.

Detailed description

(Details available on request)

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	Artemether + lumefantrine	A single adult dose of artemether-lumefantrine will be administered on a unique occasion together with food. Venous and capillary blood samples will be collected at 6 to 10 time points, as defined before drug administration with each volunteer.

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-07-01
• Completion: 2016-09-01
• First posted: 2016-04-19
• Last updated: 2018-01-16

Locations

1 site across 1 country: Switzerland