Safety, Tolerability, and Pharmacokinetic Study of Methylene Blue Following a [amount hidden] Intravenous Dose in Healthy Adults

What Was Tested

This registered phase 1 trial tested Methylene blue (non-peptide stack partner).

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

More on the Plan

This is an open-label, single-center, one-arm, safety, tolerability, and PK study in healthy male and female volunteers of Methylene Blue Injection, USP.

Who Took Part

The registry lists 12 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: Healthy adult male or female volunteers, 18-60 years of age, inclusive. Females of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Day 1:. Hysteroscopic tubal ligation (with a copy of the confirmation test) and be using a barrier method (condom or diaphragm) and spermicide throughout the study;. Bilateral tubal ligation and be using a barrier method (condom or diaphragm) and spermicide throughout the study;. Males must use condom with spermicide when engaged in sexual activity and must agree to refrain from sperm donation from check-in through 90 days postdose.

The full record lists 11 inclusion and 21 exclusion criteria; among the exclusions: give voluntary written informed consent to participate in the study; be able to comply with the protocol and the assessments therein; history or presence of alcoholism within the past 2 years.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Methylene blue (non-peptide stack partner) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2012-10 with completion listed for 2012-10.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC 0-t). Area Under the Curve From Time Zero Extrapolated to Infinity (AUC 0-∞). The Percent of Extrapolated Area Under the Curve (AUC%Extrap).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Methylene blue (non-peptide stack partner) in 12 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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