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NCT Number: NCT04449536

Cysteine-lowering Treatment With Mesna

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.

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Key information

Conditions

Obesity Body Weight Drug Effect Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University of Oslo

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesna

Drug

Administration of a single oral dose, using film-coated tablets of either 400 mg or 600 mg or a combination of maximum 3 tablets up to a maximum of 1600 mg

Other names: Uromitexan

Primary outcomes

  1. Change in plasma total cysteine concentrations following single ascending doses of oral Mesna.

    Time frame: Several intervals during the first 12 hours after Mensa administration, and a fasting sample on days 2 and 3

    Nadir plasma total cysteine concentrations

Secondary outcomes

  1. Pharmacokinetic parameter - maximum plasma concentration (Cmax)

    Time frame: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3

    Maximum plasma Mesna concentration (Cmax) after a single oral Mesna dose

  2. Pharmacokinetic parameter - time to maximum plasma concentration (Tmax)

    Time frame: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3

    Time to maximum plasma Mesna concentration (Tmax) after a single oral Mesna dose

  3. Pharmacokinetic parameter - area under the plasma concentration-time curve (AUC)

    Time frame: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3

    Area under the plasma Mesna concentration-time curve (AUC)0-inf after a single oral Mesna dose

  4. Pharmacokinetic parameter - elimination rate constant (Kel)

    Time frame: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3

    Elimination rate constant (Kel) for Mesna after a single oral Mesna dose

  5. Pharmacokinetic parameter - dose linearity

    Time frame: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3

    Dose linearity of Mesna after a single oral Mesna dose

  6. Change in plasma cystine, free reduced cysteine, and protein bound cysteine

    Time frame: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3

    Estimated AUCs

  7. Urine excretion of cysteine

    Time frame: During the first 24 hours after Mesna administration

    Cumulative and fractional excretion of total cysteine and Mesna

  8. Safety of Mesna

    Time frame: During the first 5 days after Mesna administration

    Occurrence/prevalence of side effects, adverse events, and serious adverse events

Other outcomes

  1. Changes in plasma and urine sulfur amino acids and related metabolites

    Time frame: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3

    Estimated AUCs

  2. Changes in plasma biomarker concentration - glucose

    Time frame: During the first 24 hours after Mesna administration, and a fasting sample on days 2 and 3

    Estimated AUC

  3. Changes in plasma biomarker concentration - insulin

    Time frame: During the first 24 hours after Mesna administration, and a fasting sample on days 2 and 3

    Estimated AUC

  4. Changes in plasma biomarker concentration - lipids

    Time frame: During the first 24 hours after Mesna administration, and a fasting sample on days 2 and 3

    Estimated AUC

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Oslo University Hospital
  • University of Oxford

Registry information

Official study title

Cysteine-lowering Treatment With Mesna Against Obesity: Phase I Dose-finding Study

Acronym: CYLOB

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 29, 2020
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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