CompletedPhase 1

Primaquine Enantiomers in G6PD Deficient Human Volunteers

United States18 participantsStarted 2020-09-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Methemoglobin concentration in blood from baseline

Timeframe: Days 0, 3, 5

Trial details

NCT IDNCT04073953

SponsorUniversity of Mississippi, Oxford

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-01

View on ClinicalTrials.gov More G6PD Deficiency trials