A RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, ASCENDING MULTIPLE ORAL DOSE, SAFETY, TOLERABILITY, PHARMACOKINETIC AND PROOF OF MECHANISM STUDY OF CB-189,625 IN HEALTHY MALE SUBJECTS.
Completed
- Conditions
- Acute- en chronische pijnAcute and chronic pain
- Registration Number
- NL-OMON37104
- Lead Sponsor
- PRA International EDS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Healthy male volunteers
Age : 18-55 jaar, inclusive
BMI: 18.0 * 30.0 kg/m2, inclusive
non-smoking
Exclusion Criteria
Suffering from: hepatitis B. cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of the study. In case of donating blood or significant loss of blood within 90 days of the start of drug dosing.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety and tolerability: adverse events, clinical laboratory data, vital signs,<br /><br>ECG, physical examination.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmakinetics parameters:<br /><br>Analysis of variance (four factor-ANOVA) on Cmax and AUC, other parameters<br /><br>descriptive statistics<br /><br><br /><br>Pharmacodynamic parameters:<br /><br>Analysis of mosterd oil and cinnamaldehyde challenges in healthy volunteers.<br /><br><br /><br>Safety parameters:<br /><br>Descriptive statistics.</p><br>
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 molecular mechanisms does CB-189,625 target to modulate acute and chronic pain pathways in the NL-OMON37104 MAD/POM study?
How does CB-189,625's analgesic efficacy and safety profile compare to standard-of-care treatments like NSAIDs or opioids in preclinical and early-phase trials?
Which biomarkers are associated with response prediction to CB-189,625 in pain management studies, particularly in healthy male subjects?
What are the known or potential adverse events of CB-189,625 in ascending multiple oral dose trials, and how are they managed in early-phase studies?
Are there other novel analgesic compounds or combination therapies targeting similar pain mechanisms as CB-189,625 in the NL-OMON37104 trial?