neuropathic pain
Conditions
Interventions
The study will consist of 6 groups, each group will stay in the clinical
research centre for 2 periods of 5 days (4 nights) each (Day -1 to 4 and Day 28
to 32).
During the study subjects will rece
after this they will have to drink 240 mL
of water. One (1) hour after the intake of the study medication they will
receive an additional 240 mL of water. During the study they will receive GRT
601
we call this *the study is blinded*. However, information on the administration
of study medication will be present in the clinical research facility, in
sealed envelopes, which can be opened in cas
Sponsors
Grunenthal
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: healthy male subjects 18-45 yrs, inclusive BMI: 18.0-30.0 kg/m2, inclusive non- or moderate smoking
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Leukocyte CD11b expression levels, plasma nociceptin concentrations | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Pharmacokinetics Pharmacodynamics Tolerability | — |
Countries
Netherlands
Outcome results
None listed