HealthyPhase 1TSTSNCT02624479
Pharmacokinetic Study to Investigate the Bioavailability and Tolerability of 3 Oral Formulations of Sodium Thiosulfate
A Phase 1 study testing Sodium thiosulfate in people with Healthy, run by Insel Gruppe AG, University Hospital Bern.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sodium thiosulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: Phase I Pharmacokinetic Pilot Study to Investigate the Bioavailability and Tolerability of Three Different Oral Formulations of Sodium Thiosulfate
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
- Being tested
- Sodium thiosulfate
- Keywords
- Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium thiosulfateDrug
oral administration of thiosulfate
| Study group | Role | What they receive |
|---|---|---|
| Fast first | Experimental | Sodium thiosulfate fast release formulation first, followed by medium and slow Receives: Drug: Sodium thiosulfate |
| Medium first | Experimental | Sodium thiosulfate medium release formulation first, followed by slow and fast Receives: Drug: Sodium thiosulfate |
| Slow first | Experimental | Sodium thiosulfate slow release formulation first, followed by fast and medium Receives: Drug: Sodium thiosulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability of STS after oral administration based on urinary excretion of TS and sulfate
Measured: 7 weeks
Secondary outcomes (6)
Number of participants with treatment-related adverse events
Measured: 7 weeks
TS excretion in urine
amount excreted within 48h and fraction (amount/dose) of administered thiosulfate
Measured: 48 hours
TS excretion in urine: amount
amount excreted within 48h
Measured: 48 hours
TS excretion in urine: fraction of administered TS
excreted / administered
Measured: 48 hours
Sulfate excretion in urine: amount
amount excreted within 48h
Measured: 48 hours
Sulfate excretion in urine: fraction of administered TS
excreted / administered
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startDec 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Formulations could never be successfully produced
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominik Uehlinger, Prof Dr.med., Study chair, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624479
- Sponsor's protocol ID
- 009_15
- Acronym
- TSTS
- Status last verified
- Feb 2023
- First submitted
- 26 Nov 2015
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Pharmacokinetic Pilot Study to Investigate the Bioavailability and Tolerability of Three Different Oral Formulations of Sodium Thiosulfate
- ClinicalTrials.gov ID
- NCT02624479
- Acronym / sponsor ID
- TSTS / 009_15
- Conditions
- Healthy
- Keywords
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Formulations could never be successfully produced
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fast first | Experimental | Drug: Sodium thiosulfateSodium thiosulfate fast release formulation first, followed by medium and slow |
| Medium first | Experimental | Drug: Sodium thiosulfateSodium thiosulfate medium release formulation first, followed by slow and fast |
| Slow first | Experimental | Drug: Sodium thiosulfateSodium thiosulfate slow release formulation first, followed by fast and medium |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium thiosulfateoral administration of thiosulfate | Drug | Fast first, Medium first, Slow first |
Primary outcome
Relative bioavailability of STS after oral administration based on urinary excretion of TS and sulfate
Time frame: 7 weeks
6 secondary outcomes
Number of participants with treatment-related adverse events
Time frame: 7 weeks
TS excretion in urine
Time frame: 48 hours
TS excretion in urine: amount
Time frame: 48 hours
TS excretion in urine: fraction of administered TS
Time frame: 48 hours
Sulfate excretion in urine: amount
Time frame: 48 hours
Sulfate excretion in urine: fraction of administered TS
Time frame: 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominik Uehlinger, Prof Dr.med. study chair
Insel Gruppe AG, University Hospital Bern
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sodium thiosulfate in people with Healthy, run by Insel Gruppe AG, University Hospital Bern.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative bioavailability of STS after oral administration based on urinary excretion of TS and sulfate (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.