Study of the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral dosing in healthy subjects including brain Serotonin Transporter (SERT) occupancy by Positron Emission Tomography (PET).
- Conditions
- chronische pijn aan beschadigde organen.visceral pain
- Registration Number
- NL-OMON34068
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 51
Healthy male or female (post-menopausal or surgically sterile), age between18 and 65 years, BMI between 19 and 32.5 kg/m2, non-smoker or light to moderate smoker, at screening state of healthy must satisfy the entry requirements.;Addition 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.
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 60 days from the start of the study. In case of donating more than 1.5 liters (for men)/1.0 liters (for women) 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, Pharmacokinetics, Safety.</p><br>
- Secondary Outcome Measures
Name Time Method <p>n.a.</p><br>