Primary:- to evaluate the safety and tolerability of the compound in different multiple dosing regimens in healthy subjects in different dosing regimensSecondary:- to characterize the pharmacokinetics of multiple oral doses of LY2878735 administered…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
chronische pijn aan beschadigde organen.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacodynamics, Pharmacokinetics, Safety.
Secondary outcome
n.a.
Background summary
The drug to be given is a new investigational compound that may eventually be
used for the treatment of chronic pain that is caused by damaged or injured
internal organs (visceral pain). Visceral pain is by far, the most common form
of pain.
Few drugs have been approved for specific visceral pain conditions, and current
therapies offer limited efficacy.
The compound is a potent and selective serotonine/norepinephrine (5-HT/NE)
reuptake inhibitor (SNRI). SNRIs are utilized in the treatment of depression
and chronic pain. SNRIs increase the levels of both serotonin and
norepinephrine by inhibiting their reabsorption (reuptake) into the cells in
the brain. Serotonin and norepinephrine are both known to play an important
part in mood. Elevation of norepinephrine is thought to be necessary to be
effective against pain as well.
Study objective
Primary:
- to evaluate the safety and tolerability of the compound in different multiple
dosing regimens in healthy subjects in different dosing regimens
Secondary:
- to characterize the pharmacokinetics of multiple oral doses of LY2878735
administered to healthy subjects in different dosing regimens
- to evaluate the effect of LY2878735 on the change from baseline in plasma
concentrations of norepinephrine and its metabolite dihydroxyphenylglycol as an
indirect measure of norepinephrine activity
- to evaluate the effect of LY2878735 on the change from baseline in ex vivo
norepinephrine/serotonin uptake inhibition
- to explore the relationship between dose/exposure of LY2878735 and brain
serotonin receptor transporter (SERT) occupancy after multiple oral doses in
healthy subjects by direct measurement with Positron Emission Tomography (PET)
using 11C-DASB ligand
Study design
Part A:
A randomized, double-blind, placebo-controlled, multiple-ascending dose study.
Part B:
An open-label PET study.
Part C (optional):
A randomized, double-blind, placebo-controlled, multiple-ascending dose study.
Intervention
Active substance: LY2878735
Study burden and risks
Procedures: pain, light bleeding, heamatoma, possibly an infection.
Lilly Corporate Center
Indianapolis, 46285
United States of America
Lilly Corporate Center
Indianapolis, 46285
United States of America
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-020231-39-NL |
| Other | n.a. |
| CCMO | NL32452.056.10 |