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

Insel Gruppe AG, University Hospital Bern

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Drug: Sodium thiosulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT02624479

009_15

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 120 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 3 patient groups

Fast first

Experimental group

Description:

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

Treatment:

Drug: Sodium thiosulfate

Medium first

Experimental group

Description:

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

Treatment:

Drug: Sodium thiosulfate

Slow first

Experimental group

Description:

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

Treatment:

Drug: Sodium thiosulfate