Cysteine-lowering Treatment With Mesna (CYLOB)

May 18, 2022 updated by: Kathrine Vinknes, University of Oslo

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • University of Oslo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Mesna
Administration of a single oral dose of 400 mg, 800 mg, 1200 mg or 1600 mg
Drug: Mesna
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Several intervals during the first 12 hours after Mensa administration, and a fasting sample on days 2 and 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3
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
Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 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
Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3
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
Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3
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
Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3
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
Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3
Urine excretion of cysteine
Time Frame: During the first 24 hours after Mesna administration
Cumulative and fractional excretion of total cysteine and Mesna
During the first 24 hours after Mesna administration
Safety of Mesna
Time Frame: During the first 5 days after Mesna administration
Occurrence/prevalence of side effects, adverse events, and serious adverse events
During the first 5 days after Mesna administration

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3
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
During the first 24 hours after Mesna administration, and a fasting sample on days 2 and 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
During the first 24 hours after Mesna administration, and a fasting sample on days 2 and 3
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
During the first 24 hours after Mesna administration, and a fasting sample on days 2 and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oslo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Oslo University Hospital
University of Oxford

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kjetil Retterstøl, MD, PhD, University of Oslo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 21, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EudraCT: 2019-003412-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data that support the findings of this study may be available upon reasonable request from qualified users.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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