A Phase 1 interventional study of RPQ and SPQ in G6PD Deficiency, sponsored by University of Mississippi, Oxford. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by University of Mississippi, Oxford · Phase 1, Interventional, and Basic science
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.
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 the general CMP14 safety criteria, any subject who displays a fractional hemoglobin drop of 15% below his/her baseline value, then drug administration will stop (e.g. for baseline Hgb of 14 g/dL, if there is at any point a decrease of 2.1 g/dL). Hematocrit will be similarly monitored, with proportional stop criteria. Elevation in total bilirubin to 2.0 mg/dL or greater will also be used as a stopping criterion. After stopping drug administration (5 days or whenever stop criteria are met), subjects will have a 3-week washout period, and the study repeated with the other enantiomer, and similarly with Placebo.
35 studies on the registry are indexed under Glucosephosphate Dehydrogenase Deficiency; 4 are open to participants now.
This study's enrollment of 18 is below the median of 100 across 23 interventional studies indexed under Glucosephosphate Dehydrogenase Deficiency.
Browse Glucosephosphate Dehydrogenase Deficiency studies →University of Mississippi, Oxford is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Cohort 1 will receive 15mg of RPQ every day for 5 days. Cohort 2 will receive 22.5 mg of RPQ every day for five days.
Drug: RPQ
Cohort 1 will receive 15mg of SPQ every day for 5 days. Cohort 2 will receive 22.5 mg of SPQ every day for five days.
Drug: SPQ
Cohort 1 will receive placebo capsules every day for 5 days. Cohort 2 will receive placebo capsules every day for five days.
Drug: Placebo
The study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo.
Also known as: R-(-) Enantiomer of Primiquine Phosphate
The study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo.
Also known as: S-(+) Enantiomer of Primaquine Phosphate
The study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo.
Change in Methemoglobin concentration in blood from baseline
Change in Methemoglobin concentration in blood from baseline (% hemoglobin)
Time frame: Days 0, 3, 5
Primaquine Plasma Concentration, ng/mL
Plasma concentrations of parent drug
Time frame: Days 0, 3, 5
Carboxy-Primaquine Plasma Contration, ng/mL
Plasma concentrations of carboxy-primaquine metabolite
Time frame: Days 0, 3, 5
Primaquine N-carbamoyl-glucuronide Plasma contration, ng/mL
Plasma concentrations of Primaquine N-carbamoyl-glucuronide metabolite
Time frame: Days 0, 3, 5
Primaquine Orthoquinone Plasma concentration, ng/mL
Plasma concentrations of Primaquine Orthoquinone metabolite
Time frame: Days 0, 3, 5
Change in Hematocrit (%) compared to baseline
Change in Hematocrit (%) compared to baseline
Time frame: Days 0, 3, 5
Change in Hemoglobin (g/dL) compared to baseline
Change in Hemoglobin (g/dL) compared to baseline
Time frame: Days 0, 3, 5
Change is AST (U/L) compared to baseline
Change is AST (U/L) compared to baseline; used to monitor liver function
Time frame: Days 0, 3, 5
Change in ALT (U/L) compared to baseline
Change in ALT (U/L) compared to baseline; used to monitor liver function
Time frame: Days 0, 3, 5
Change in total Bilirubin (mg/dL) compared to baseline
Change in total Bilirubin (mg/dL) compared to baseline; used to monitor liver function and red cell integrity
Time frame: Days 0, 3, 5
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Glucosephosphate Dehydrogenase Deficiency →
University of Mississippi, Oxford