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

Phase 1

Withdrawn

• Conditions: Healthy
• Interventions: Drug: Sodium thiosulfate

• Registration Number: NCT02624479
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-26
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-08
• Study Start: 2018-12
• Primary Completion: 2019-05
• Study Completion: 2019-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Medium first	Sodium thiosulfate	Sodium thiosulfate medium release formulation first, followed by slow and fast
Slow first	Sodium thiosulfate	Sodium thiosulfate slow release formulation first, followed by fast and medium
Fast first	Sodium thiosulfate	Sodium thiosulfate fast release formulation first, followed by medium and slow

Primary Outcome Measures

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

Secondary Outcome Measures

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