inflammation induced pain nociceptive pain sensitization induced pain
Conditions
Interventions
None listed
Sponsors
Galapagos NV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject has signed the informed consent form prior to any study related activity. 2. Subject is a healthy male volunteer between 18 and 65 years) of age (inclusive) at the screening (inclusive). 3. Subject has a BMI * 18.0 kg/m2 and * 30.0 kg/m2 at the screening. 4. Subject is appropriate for the study in the judgment of the investigator, based on physical examination, 12-lead electrocardiogram (ECG), laboratory tests, and subject*s interview. 5. Subject has a high probability for compliance with and completion of the study. 6. Subject agrees that he will use a condom and that in addition to that he (and his female partner of child-bearing potential) will use a highly effective method of contraception and will not donate sperm from first dose administration to 12 weeks after the last dose administration 7. Subject is non-smoker or is a light smoker (up to 5 cigarettes a day) and has not used more than the equivalent of 5 cigarettes a day of nicotine-containing products for at least 6 months. 8. Subject has skin type 1 or 2 according to Fitzpatrick Skin Typing Test.
Exclusion criteria
Exclusion criteria: 1. Subject shows clinically significant abnormalities in physical examination, ECG or vital signs, according to the investigator*s judgment. 2. Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases. 3. History of malignancy in the last 5 years, except basal cell carcinoma of the skin that has been treated and with no evidence of recurrence. 4. Subject has been exposed to GLPG1205 before. 5. Known hypersensitivity to GLPG1205 or excipients of the formulation. History of significant allergic reaction to any drug, such as anaphylaxis requiring hospitalization. 6. Subject had major surgery, donated or lost 1 unit of blood or plasma (approximately 500 mL) within 6 weeks prior to the first intake of the study drug. 7. Subject has participated in another investigational trial within 90 days prior to the intake of the study drug of this study. 8. Subject has used any prescription drug or herbal medicine within 14 days, over-the-counter medications or vitamin supplements within 7 days prior to Day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints (preventative setting) HPTol at Day=6 (24h post-UVB exposure) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints (preventative setting): * HPTol at Day 6 * HPThr at Day 6 * CPT at Day 6 * MDT at Day 6 * MPT at Day 6 * HPTol, HPThr, CPT, MDT, MPT time profile Secondary Endpoints (therapeutic setting): * HPThr Day 1 * HPTol Day 1 * CPT Day 1 * MDT Day 1 * MPT Day 1 * HPTol, HPThr, CPT, MDT, MPT time profile | — |
Countries
Netherlands
Outcome results
None listed