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Phase2a Primaquine Dose Escalation Study

NCT01743820 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2015-01-19

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against P.falciparum among adult glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.

Conditions

Interventions

DRUG

dihydroartemisinin-piperaquine

DRUG

0.125 mg/kg Primaquine

DRUG

0.5 mg/kg Primaquine

DRUG

0.25 mg/kg Primaquine

DRUG

0.0625 mg/kg Primaquine

Sponsors & Collaborators

  • Malaria Research and Training Center, Bamako, Mali

    collaborator OTHER

  • Shoklo Malaria Research Unit

    collaborator OTHER

  • Mahidol Oxford Tropical Medicine Research Unit

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Wellcome Trust

    collaborator OTHER

  • University of California, San Francisco

    lead OTHER

Principal Investigators

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

  • Alassane Dicko, MD · Malaria Research and Training Centre

  • François Nosten, MD · Shoklo Malaria Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-12-31
Completion
2014-12-31

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 NCT01743820 on ClinicalTrials.gov