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

Healthy Clinical Trial

— TSTS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02624479
• Other study ID #: 009_15
• Status: Withdrawn
• Phase: Phase 1
• Start date: December 2018
• Est. completion date: December 2019

Study information

• Verified date: February 2023
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Sodium thiosulfate
oral administration of thiosulfate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative bioavailability of STS after oral administration based on urinary excretion of TS and sulfate		7 weeks
Secondary	Number of participants with treatment-related adverse events		7 weeks
Secondary	TS excretion in urine	amount excreted within 48h and fraction (amount/dose) of administered thiosulfate	48 hours
Secondary	TS excretion in urine: amount	amount excreted within 48h	48 hours
Secondary	TS excretion in urine: fraction of administered TS	excreted / administered	48 hours
Secondary	Sulfate excretion in urine: amount	amount excreted within 48h	48 hours
Secondary	Sulfate excretion in urine: fraction of administered TS	excreted / administered	48 hours