Metabolism and Pharmacokinetics of Primaquine Enantiomers in Human Volunteers Receiving a Seven Day Dose Regimen

• Status: Completed
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the comparative tolerability, metabolism and pharmacokinetics of individual enantiomers of PQ in healthy human volunteers, receiving study drug over the course of 7 days.

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

Details

• Lead Sponsor: University of Mississippi, Oxford
• Treatments: Primaquine

Criteria

Inclusion Criteria:

• Normal, healthy adults aged 18 to 65 years

Exclusion Criteria:

• Known history of liver, kidney or hematological disease

• Known history of cardiac disease, Non Sinus Rhythm arrhythmia or QT prolongation

• Autoimmune disorders

• Report of an active infection

• Evidence of G6PD deficiency

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