Primaquine Enantiomers in G6PD Deficient Human Volunteers

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a single center, prospective, cross-over phase 1 trial. Eighteen subjects will be enrolled in the study evaluating the metabolism, pharmacokinetic behavior and tolerability of primaquine enantiomers and placebo over the course of 5 days.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Mississippi, Oxford
• Collaborators: Southern Research; Southern Research Institute; University of Colorado, Denver
• Treatments: Primaquine

Criteria

Inclusion Criteria:

• G6PD deficient, otherwise normal healthy adults aged 18 to 65

Exclusion Criteria:

• Known history of liver, kidney or hematological disease (other than G6PD deficiency)

• Known history of cardiac disease, non-sinus rhythm arrhythmia or QT prolongation

• Autoimmune disorders

• Report of an active infection

• Subject is pregnant or breast-feeding, or is expecting to conceive during the study.