Skip to main content
OpenTrials
Completed

NCT Number: NCT04073953

Primaquine Enantiomers in G6PD Deficient Human Volunteers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

G6PD Deficiency Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Glucosephosphate Dehydrogenase Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Hemolysis Infections Malaria Metabolic Diseases Metabolism, Inborn Errors Mosquito-Borne Diseases Nutritional and Metabolic Diseases Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Protozoan Infections Vector Borne Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Mississippi

University, Mississippi, 38677, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RPQ

Drug

The study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo.

Other names: R-(-) Enantiomer of Primiquine Phosphate

SPQ

Drug

The study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo.

Other names: S-(+) Enantiomer of Primaquine Phosphate

Placebo

Drug

The study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo.

Primary outcomes

  1. Change in Methemoglobin concentration in blood from baseline

    Time frame: Days 0, 3, 5

    Change in Methemoglobin concentration in blood from baseline (% hemoglobin)

Secondary outcomes

  1. Primaquine Plasma Concentration, ng/mL

    Time frame: Days 0, 3, 5

    Plasma concentrations of parent drug

  2. Carboxy-Primaquine Plasma Contration, ng/mL

    Time frame: Days 0, 3, 5

    Plasma concentrations of carboxy-primaquine metabolite

  3. Primaquine N-carbamoyl-glucuronide Plasma contration, ng/mL

    Time frame: Days 0, 3, 5

    Plasma concentrations of Primaquine N-carbamoyl-glucuronide metabolite

  4. Primaquine Orthoquinone Plasma concentration, ng/mL

    Time frame: Days 0, 3, 5

    Plasma concentrations of Primaquine Orthoquinone metabolite

  5. Change in Hematocrit (%) compared to baseline

    Time frame: Days 0, 3, 5

    Change in Hematocrit (%) compared to baseline

  6. Change in Hemoglobin (g/dL) compared to baseline

    Time frame: Days 0, 3, 5

    Change in Hemoglobin (g/dL) compared to baseline

  7. Change is AST (U/L) compared to baseline

    Time frame: Days 0, 3, 5

    Change is AST (U/L) compared to baseline; used to monitor liver function

  8. Change in ALT (U/L) compared to baseline

    Time frame: Days 0, 3, 5

    Change in ALT (U/L) compared to baseline; used to monitor liver function

  9. Change in total Bilirubin (mg/dL) compared to baseline

    Time frame: Days 0, 3, 5

    Change in total Bilirubin (mg/dL) compared to baseline; used to monitor liver function and red cell integrity

Sponsors and collaborators

Lead sponsor

University of Mississippi, Oxford

Other

Collaborators

  • University of Colorado, Denver

Registry information

Official study title

Metabolism and Pharmacokinetics of Primaquine Enantiomers in G6PD Deficient Human Volunteers Receiving a Five Day Dose Regimen

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 29, 2019
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.