Cysteine-lowering Treatment With Mesna (CYLOB)

University of Oslo

Status and phase

Completed

Phase 1

Conditions

Obesity

Drug Effect

Treatments

Drug: Mesna

Study type

Interventional

Funder types

Other

Identifiers

NCT04449536

EudraCT: 2019-003412-32

Details and patient eligibility

About

The primary objective of this study is to determine the efficacy of the drug Mesna® (Uromitexan) in healthy participants with overweight or obesity with respect to change in plasma concentrations of total cysteine, following single ascending doses of oral Mesna.

Full description

In both animal experiments and human studies, cysteine in the blood is strongly associated with obesity. In rodents, changes in cysteine induced by dietary means are accompanied by changes in fat mass.

In this phase I, single ascending dose study the investigators will determine the effects of Mesna in healthy volunteers with overweight and obesity with focus on its effects on plasma total cysteine concentrations. The aim of this dose-finding clinical trial is to determine the lowest single oral Mesna dose that will lower plasma total cysteine concentrations by 30% using pharmacokinetic (PK)/ pharmacodynamic (PD) modelling. The investigators will further evaluate the effect of Mesna on plasma cysteine fractions and related metabolites, urinary cysteine excretion, safety and adverse drug reactions, and plasma biomarkers.

Enrollment

25 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

BMI between BMI 27-40 kg/m2
Age between 18-55 years
Male
Healthy as determined by medical evaluation, medical history, physical examination, 12-lead ECG, and laboratory tests

Exclusion criteria

Presence of chronic disease
Chronic drug use
Past or intended use of over-the-counter or prescription medication including herbal medications within 14 days prior to dosing
Veganism
Strenuous physical activity ≥3 times every week
Smoking