A first-in-human single-dose escalation study of the safety, pharmacokinetics and pharmacodynamics of the test drug including brain Serotonin Receptor Transporter (SERT) occupancy by Positron Emission Tomography (PET).
Completed
- Conditions
- pijn aan beschadigde organenvisceral pain
- Registration Number
- NL-OMON34991
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 38
Inclusion Criteria
Healthy male, age between 18 and 65 years, BMI between 19 and 32.5 kg/m2, non-smoker or moderate smoker, at screening state of health must satisfy the entry requirements. ;Only part B:
Non-exposure to any radiation for diagnostic reasons during work or during participation in a medical trial in the past year, non claustrophobic.
Exclusion Criteria
D5a:
Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 90 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>Pharmacodynamics: plasma DHPG and NE concentrations, NE/5-HT uptake inhibition,<br /><br>occupancy of transporter sites<br /><br>Pharmacokinetics: plasma concentrations, pharmacokinetic parameters<br /><br>Safety: adverse events, vital signs, ECG-parameters, laboratory parameters,<br /><br>physical examination</p><br>
- Secondary Outcome Measures
Name Time Method <p>n.a.</p><br>