Pharmacokinetic Study to Investigate the Bioavailability and Tolerability of 3 Oral Formulations of Sodium Thiosulfate (TSTS)

February 7, 2023 updated by: University Hospital Inselspital, Berne

Phase I Pharmacokinetic Pilot Study to Investigate the Bioavailability and Tolerability of Three Different Oral Formulations of Sodium Thiosulfate

Chronic treatment and prophylaxis of vessel and soft tissue calcification as well as of renal calculi could be a future indication for sodium thiosulfate (STS). Using an oral formulation might increase the compliance and treatment success compared to parenteral administration.

Three gastro-resistant formulations of STS for oral administration were developed with different release characteristics: fast-release, medium-release and slow-release tablets. Aim of the enteric coating was to increase the oral bioavailability of STS. The bioavailability and tolerability of these formulations for oral administration in healthy volunteers will be compared in this clinical trial.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • 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 Contact

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

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female healthy subjects ≥ 18 years
  • Negative pregnancy test in female subjects of childbearing age
  • Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study

Exclusion Criteria:

  • Pregnant or lactating subjects.
  • Renal impairment (creatinine clearance <60ml/min)
  • Concomitant medication
  • Gastrointestinal diseases
  • History of alcohol abuse, illicit drug use, significant mental illness, physical dependance to opioid, other drug abuse or addiction (last 12 months)

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: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fast first
Sodium thiosulfate fast release formulation first, followed by medium and slow
Drug: Sodium thiosulfate
oral administration of thiosulfate
EXPERIMENTAL: Medium first
Sodium thiosulfate medium release formulation first, followed by slow and fast
Drug: Sodium thiosulfate
oral administration of thiosulfate
EXPERIMENTAL: Slow first
Sodium thiosulfate slow release formulation first, followed by fast and medium
Drug: Sodium thiosulfate
oral administration of thiosulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relative bioavailability of STS after oral administration based on urinary excretion of TS and sulfate
Time Frame: 7 weeks
7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events
Time Frame: 7 weeks
7 weeks
TS excretion in urine
Time Frame: 48 hours
amount excreted within 48h and fraction (amount/dose) of administered thiosulfate
48 hours
TS excretion in urine: amount
Time Frame: 48 hours
amount excreted within 48h
48 hours
TS excretion in urine: fraction of administered TS
Time Frame: 48 hours
excreted / administered
48 hours
Sulfate excretion in urine: amount
Time Frame: 48 hours
amount excreted within 48h
48 hours
Sulfate excretion in urine: fraction of administered TS
Time Frame: 48 hours
excreted / administered
48 hours

Collaborators and Investigators

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

Sponsor

University Hospital Inselspital, Berne

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 (ANTICIPATED)

December 1, 2018

Primary Completion (ANTICIPATED)

May 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

November 26, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (ESTIMATE)

December 8, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 009_15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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