Cysteine-lowering Treatment With Mesna

NCT04449536 | Completed Phase 1

• 1 other identifier: EudraCT: 2019-003412-32
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Drug Effect

Keywords

Cysteine; Phase 1; Mesna

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (8)

• Pharmacokinetic parameter - maximum plasma concentration (Cmax)

  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)

  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)

  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)

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

• Pharmacokinetic parameter - dose linearity

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

Other Outcomes (4)

• Changes in plasma and urine sulfur amino acids and related metabolites

  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

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

• Changes in plasma biomarker concentration - insulin

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

Study Arms (1)

Mesna

EXPERIMENTAL

Administration of a single oral dose of 400 mg, 800 mg, 1200 mg or 1600 mg

Drug: Mesna

Interventions

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

Also known as: Uromitexan

Mesna

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oslo: lead
• Oslo University Hospital: collaborator
• University of Oxford: collaborator

Study Sites (1)

University of Oslo

Oslo, Norway

Location

MeSH Terms

Conditions

Obesity

Interventions

Mesna

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids

Study Officials

• Kjetil Retterstøl, MD, PhD

  University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher and Project manager

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 29, 2020
• Study Start: November 2, 2020
• Primary Completion: October 21, 2021
• Study Completion: October 21, 2021
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)