SafetyPhase 1NCT01269476
Safety and Pharmacokinetics of SNX-001 in Healthy Aged Volunteers
A Phase 1 study testing SNX-001 in people with Safety, run by SeneXta Therapeutics SA at 1 site in Germany.
Trial summary
This is a randomised, double-blind, group-sequential, placebo-controlled, safety and pharmacokinetic study in healthy, aged volunteers. Objectives: 1. to confirm the previously reported safety profile of oral SNX-001 after single and multiple doses of 3.6, 7.2 or 10.8 mg compared to placebo 2. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Safety
- What is being tested?
- SNX-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2009to Aug 2010
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males or females
- Physically and mentally healthy subjects
- Body weight >60 kg and body weight ≤ 100 kg
Who cannot join
- Evidence of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, haematological, psychiatric, neurological or other significant acute or chronic abnormalities
- History of general malignant diseases
- Evidence of myasthenic weakness
- Acute infection or any other febrile illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Safety and Pharmacokinetics of Methane Sulfonylfluoride (MSF or SNX-001) After Single and Multiple Oral Dose Administration in Healthy Adult Aged Volunteers
This is a randomised, double-blind, group-sequential, placebo-controlled, safety and pharmacokinetic study in healthy, aged volunteers.
Objectives:
- to confirm the previously reported safety profile of oral SNX-001 after single and multiple doses of 3.6, 7.2 or 10.8 mg compared to placebo
- to establish SNX-001 pharmacokinetic profile.
Read the detailed description
This study is an exploratory study designed as a group sequential single and multiple escalating dose, double-blind within cohort, randomized, placebo controlled study to investigate the safety and tolerability as well as the pharmacokinetics and pharmacodynamics of SNX-001 given as oral doses in aged volunteers.
- Conditions
- Safety
- Being tested
- SNX-001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNX-001Drug
Also called methanesulfonyl fluoride, MSF
3.6, 7.2, or 10.8 mg single dose or t.i.w.
PlaceboDrug
Also called Oil vehicle
Same volumes and frequency as active.
| Study group | Role | What they receive |
|---|---|---|
| SNX-001 | Experimental | Not described Receives: Drug: SNX-001 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship of clinical safety measurements to dose
Adverse events (AEs), vital signs, electrocardiogram (ECG), Acetylcholinesterase (AChE) inhibition, laboratory parameters after single and multiple dose administration
Measured: Throughout 14-day study period (Days 1, 2, 3, 10, 12, 13, 14) and 7 days after last dose (Day 21)
Secondary outcomes (1)
Effect of dose on pharmacokinetic (PK) parameters
Pharmacokinetic parameters after single and multiple dose administration of SNX-001 (3.6, 7.2 and 10.8 mg)
Measured: After single (Day 1) and multiple (Day 12) doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startDec 2009
- Primary completionJun 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- SeneXta Therapeutics SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jorg Sahlmann, MD, Principal investigator, Scope Life Sciences GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269476
- Sponsor's protocol ID
- SNX-001-PH1-09
- Other IDs
- 2009-011335-13, 2009
- Status last verified
- Dec 2010
- First submitted
- 22 Sep 2010
- Last updated
- 4 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Safety and Pharmacokinetics of Methane Sulfonylfluoride (MSF or SNX-001) After Single and Multiple Oral Dose Administration in Healthy Adult Aged Volunteers
- ClinicalTrials.gov ID
- NCT01269476
- Acronym / sponsor ID
- SNX-001-PH1-09
- Conditions
- Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- SeneXta Therapeutics SAIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 4 Jan 2011 (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.
This is a randomised, double-blind, group-sequential, placebo-controlled, safety and pharmacokinetic study in healthy, aged volunteers.
Objectives:
- to confirm the previously reported safety profile of oral SNX-001 after single and multiple doses of 3.6, 7.2 or 10.8 mg compared to placebo
- to establish SNX-001 pharmacokinetic profile.
Detailed description
This study is an exploratory study designed as a group sequential single and multiple escalating dose, double-blind within cohort, randomized, placebo controlled study to investigate the safety and tolerability as well as the pharmacokinetics and pharmacodynamics of SNX-001 given as oral doses in aged volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNX-001 | Experimental | Drug: SNX-001 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males or females
- Physically and mentally healthy subjects
- Body weight >60 kg and body weight ≤ 100 kg
Key exclusion criteria (4 listed)
- Evidence of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, haematological, psychiatric, neurological or other significant acute or chronic abnormalities
- History of general malignant diseases
- Evidence of myasthenic weakness
- Acute infection or any other febrile illness
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 |
|---|---|---|
| SNX-001Also: methanesulfonyl fluoride, MSF3.6, 7.2, or 10.8 mg single dose or t.i.w. | Drug | SNX-001 |
| PlaceboAlso: Oil vehicleSame volumes and frequency as active. | Drug | Placebo |
Primary outcome
Relationship of clinical safety measurements to dose
Time frame: Throughout 14-day study period (Days 1, 2, 3, 10, 12, 13, 14) and 7 days after last dose (Day 21)
Adverse events (AEs), vital signs, electrocardiogram (ECG), Acetylcholinesterase (AChE) inhibition, laboratory parameters after single and multiple dose administration
1 secondary outcome
Effect of dose on pharmacokinetic (PK) parameters
Time frame: After single (Day 1) and multiple (Day 12) doses
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2011.
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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.
Jorg Sahlmann, MD principal investigator
Scope Life Sciences GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SNX-001 in people with Safety, run by SeneXta Therapeutics SA at 1 site in Germany.
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 4 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: finished, as of the sponsor's last update on 4 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relationship of clinical safety measurements to dose (time frame: Throughout 14-day study period (Days 1, 2, 3, 10, 12, 13, 14) and 7 days after last dose (Day 21)). 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 4 Jan 2011.