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

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02624479

Acronym

TSTS

Enrollment

Registered

2015-12-08

Start date

2018-12-31

Completion date

2019-12-31

Last updated

2023-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pharmacokinetics

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.

Interventions

DRUGSodium thiosulfate

oral administration of thiosulfate

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026