Phase2a Primaquine Dose Escalation Study

University of California, San Francisco81 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Malaria

Interventions

dihydroartemisinin-piperaquineDRUG

0.125 mg/kg PrimaquineDRUG

0.5 mg/kg PrimaquineDRUG

0.25 mg/kg PrimaquineDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male * Age \>= 18 years and \< 50 years * Malaria blood thick film positive * Presence of gametocytes on thick blood film * Agrees to admission to study ward for 26 hours post diagnosis and available for follow up visits * No allergies to study drugs * Hemoglobin \>= 8 g/dl * No evidence of severe or chronic disease * Written, informed consent

Locations (1)

Malaria Research and Training Centre

Bamako, Mali

Outcomes

Primary Outcomes

mosquito infectivity assessed through membrane feeding

Baseline, Days 1, 2, 7

Time frame: 7 days

Secondary Outcomes

gametocyte prevalence and density

Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28

Time frame: 28 days

primaquine pharmacokinetics - area under the curve (AUC) of parent drug and metabolite

Hours 1, 2, 3, 4, 6, 8, 12, 24

Time frame: 24 hours

asexual parasite prevalence and density

Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28

Time frame: 28 days

safety measurements including hemoglobin and signs of hemolysis

Baseline, Days 1, 2, 3, 7, 14, 28

Time frame: 28 days

Data from ClinicalTrials.gov

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