Pharmacokinetic and in Vitro Transmission Blocking Activities Study of Primaquine Compare to Methylene Blue in Healthy Volunteer Both G6PD Normal and G6PD Deficiency

What Was Tested

The trial (phase 1) is built around Methylene blue (non-peptide stack partner).

The emergence of partial artemisinin resistance in Plasmodium falciparum on the Cambodia-Thai border and more recently on the Myanmar-Thai border jeopardizes the renewed global efforts of control and elimination of malaria.

Mathematical models also predict that transmission blocking will be required if the goal of malaria elimination is to be achieved.

It had two arms (groups): G6PD Normal (active comparator) and G6PD deficiency (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Subjects aged between 18 years to 60 years. A female is eligible to enter and participate in this study if she is:. Of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy. Read, comprehend, and write at a sufficient level to complete study-related materials. Provide a signed and dated written informed consent prior to study participation.

The full record lists 11 inclusion and 16 exclusion criteria; among the exclusions: females who are pregnant, trying to get pregnant, or are lactating; A positive pre-study hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening; those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Methylene blue (non-peptide stack partner) study: the participants and staff both knew the treatment.

It started in 2013-07 with completion listed for 2014-10.

It ran at 1 site in Thailand.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Oocysts production in mosquitoes (time frame: 7 days). Methaemoglobin, Hematocrit and Hemoglobin levels (time frame: 7 days).

It also tracked 1 secondary outcome, for example Safety of Primaquine and Methylene Blue.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Methylene blue (non-peptide stack partner) in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.