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

Completed · Phase 1 · Has a placebo group

Conditions studied: Malaria, Glucose 6 Phosphate Dehydrogenase Deficiency

In brief

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.

Key facts

Study ID

NCT03934450

Run by

University of Mississippi, Oxford

People needed

36

Starts

2018-08-17

Expected to finish

2019-05-01

Last updated by the study team

2019-05-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Normal, healthy adults aged 18 to 65 years

You may not qualify if…

• 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.

Where it is running

• University of Mississippi — University, Mississippi, United States

Full record on ClinicalTrials.gov

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