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Determining a Tolerable Dose of Primaquine in G6PD-deficient Persons Without Malaria in Mali

NCT02535767 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-02-06

No results posted yet for this study

Summary

The purpose of this study is to determine the highest tolerable dose of primaquine within 0.75 mg/kg. A tolerable dose is defined as one in which:

* Two or fewer participants (\< 30%) experience hemolysis;
* No participant experiences a drug-related serious adverse event; and
* No participant requires a blood transfusion.

Conditions

Interventions

DRUG

Primaquine

A single low dose of primaquine will be crushed and dissolved in water, and administered in weight-based doses.

Sponsors & Collaborators

  • Malaria Research and Training Center, Bamako, Mali

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • University of Mississippi Medical Center

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Roland Gosling, PhD, MS · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Mali

Study Locations

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Entities

Diseases
Companies

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 NCT02535767 on ClinicalTrials.gov