Study to Investigate the Pharmacokinetic Profile

What Was Tested

In this phase 1 trial, researchers set out to test Tesofensine (non-peptide).

It had four arms (groups): one (experimental), one (experimental), Comperator (active comparator) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

This is a randomized, open-label, parallel-arm study in 60 healthy male subjects who meet the inclusion and none of the exclusion criteria for the study.

Who Took Part

Enrollment: 60 actual participants took part.

It was open to men only aged from 18 years up to 55 years.

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

Examples of who could join: Subject voluntarily agrees to participate in this study and signs an Independent Ethics Committee (IEC)-approved informed consent prior to performing any of the Screening Visit procedures. Males between 18 to 55 years of age, inclusive, at the Screening Visit. BMI between 18.5 and 30.0 kg/m2, inclusive, at the Screening Visit. Healthy, determined by pre-study medical evaluation (medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory evaluations).

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: subject has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs; subject has history of alcohol and/or illicit drug abuse within 2 years of entry; subject is unwilling to avoid consumption of coffee and caffeine-containing beverages within 48 hours prior to admission until discharge from the clinical site.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got Tesofensine (non-peptide) and who got the comparison, which limits bias.

The Tesofensine (non-peptide) group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Tesofensine (non-peptide) was given.

Those kept unaware of assignments: participant.

It started in 2017-12-18 with completion listed for 2018-02-06.

It ran at 1 site in Germany.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: AUC0-48.

It also tracked 2 secondary outcomes, for example Cmax and Tmax.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tesofensine (non-peptide) in 60 people.

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

More context: the Tesofensine (non-peptide) compound page, all human trials.