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Primaquine Enantiomers in G6PD Deficient Human Volunteers

U

University of Mississippi, Oxford

Status and phase

Completed
Phase 1

Conditions

G6PD Deficiency

Treatments

Drug: RPQ
Drug: SPQ
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04073953
PQ Study 3

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

18 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

18 participants in 3 patient groups, including a placebo group

RPQ (-) enantiomer
Experimental group
Description:
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.
Treatment:
Drug: RPQ
SPQ (+) enantiomer
Experimental group
Description:
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.
Treatment:
Drug: SPQ
Placebo
Placebo Comparator group
Description:
Cohort 1 will receive placebo capsules every day for 5 days. Cohort 2 will receive placebo capsules every day for five days.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Larry Walker, Ph.D.; Kerri Harrison, RN

Data sourced from clinicaltrials.gov

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