Status:
COMPLETED
Primaquine Enantiomers in G6PD Deficient Human Volunteers
Lead Sponsor:
University of Mississippi, Oxford
Collaborating Sponsors:
University of Colorado, Denver
Conditions:
G6PD Deficiency
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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...
Detailed Description
Each subject will receive a 15 mg dose of one enantiomer (SPQ or RPQ or Placebo) daily for up to 5 days, with careful monitoring of hematological parameters before and after each dose. In addition to ...
Eligibility Criteria
Inclusion
- G6PD deficient, otherwise normal healthy adults aged 18 to 65
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04073953
Start Date
September 1 2020
End Date
September 1 2023
Last Update
November 21 2024
Active Locations (1)
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1
University of Mississippi
University, Mississippi, United States, 38677