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Primaquine Enantiomers in G6PD Deficient Human Volunteers

NCT04073953 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-11-21

No results posted yet for this study

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.

Conditions

  • G6PD Deficiency

Interventions

DRUG

RPQ

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

DRUG

SPQ

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

DRUG

Placebo

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

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • University of Mississippi, Oxford

    lead OTHER

Principal Investigators

  • Larry Walker, Ph.D. · University of Mississippi Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2023-09-01
Completion
2023-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04073953 on ClinicalTrials.gov