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).

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). - MAD/PET study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34068

Enrollment

Registered

2010-05-18

Start date

2010-05-25

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronische pijn aan beschadigde organen. visceral pain

Interventions

Active substance: LY2878735

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Pharmacodynamics, Pharmacokinetics, Safety.	—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)