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

NCT02624479 | Withdrawn Phase 1

• 1 other identifier: 009_15
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Relative bioavailability of STS after oral administration based on urinary excretion of TS and sulfate

  7 weeks

Secondary Outcomes (6)

• Number of participants with treatment-related adverse events

  7 weeks

• TS excretion in urine

  48 hours

• TS excretion in urine: amount

  48 hours

• TS excretion in urine: fraction of administered TS

  48 hours

• Sulfate excretion in urine: amount

  48 hours

Study Arms (3)

Fast first

EXPERIMENTAL

Sodium thiosulfate fast release formulation first, followed by medium and slow

Drug: Sodium thiosulfate

Medium first

EXPERIMENTAL

Sodium thiosulfate medium release formulation first, followed by slow and fast

Drug: Sodium thiosulfate

Slow first

EXPERIMENTAL

Sodium thiosulfate slow release formulation first, followed by fast and medium

Drug: Sodium thiosulfate

Interventions

Sodium thiosulfate DRUG

oral administration of thiosulfate

Fast first; Medium first; Slow first

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

MeSH Terms

Interventions

sodium thiosulfate

Study Officials

• Dominik Uehlinger, Prof Dr.med.

  Insel Gruppe AG, University Hospital Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2015
• First Posted: December 8, 2015
• Study Start: December 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 9, 2023

Record last verified: 2023-02