First in Man Study With SLV341
- Registration Number
- NCT00887445
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
First in man study with single and multiple rising doses with SLV341
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 87
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A SLV341 - B placebo -
- Primary Outcome Measures
Name Time Method Safety and tolerability parameters: adverse event, vital signs, 12-Lead ECG, continuous lead II ECG monitoring, laboratory safety variables and physical examination. 7 days
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR 1 - 28 days Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring. 28 days Interaction with Midazolam 24 hours
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of SLV341 in targeting diabetes pathways in phase 1 trials?
How does SLV341 compare to standard-of-care GLP-1 agonists in early-phase glycemic control studies?
Which biomarkers correlate with SLV341's pharmacodynamic effects in young male diabetes subjects?
What adverse events were observed in Solvay's NCT00887445 trial and how were they managed?
Are there combination therapies involving SLV341 and SGLT2 inhibitors for diabetes under investigation?
Trial Locations
- Locations (1)
S341.1.001 Site #
🇬🇧London, United Kingdom
S341.1.001 Site #🇬🇧London, United Kingdom