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

NCT ID: NCT02624479

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-31
• Study Completion Date: 2019-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Fast first

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

Group Type: EXPERIMENTAL

Sodium thiosulfate

Intervention Type: DRUG

oral administration of thiosulfate

Medium first

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

Group Type: EXPERIMENTAL

Sodium thiosulfate

Intervention Type: DRUG

oral administration of thiosulfate

Slow first

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

Group Type: EXPERIMENTAL

Sodium thiosulfate

Intervention Type: DRUG

oral administration of thiosulfate

Interventions

Sodium thiosulfate

oral administration of thiosulfate

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominik Uehlinger, Prof Dr.med.

Role: STUDY_CHAIR

Insel Gruppe AG, University Hospital Bern

Other Identifiers

009_15

Identifier Type: -

Identifier Source: org_study_id