A randomized, single-center, double-blind, placebo-controlled, 2-way cross-over, single oral administration trial to evaluate blood-borne biomarker candidates to predict NOP receptor activation using GRT6010 as NOP receptor agonist in healthy human subjects.
Completed
- Conditions
- neuropathic pain10034606
- Registration Number
- NL-OMON37607
- Lead Sponsor
- Grunenthal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
healthy male subjects
18-45 yrs, inclusive
BMI: 18.0-30.0 kg/m2, inclusive
non- or moderate smoking
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Leukocyte CD11b expression levels, plasma nociceptin concentrations</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety<br /><br>Pharmacokinetics<br /><br>Pharmacodynamics<br /><br>Tolerability</p><br>