DSP-2230 Capsaicin and UVB Challenge Study
- Conditions
- Peripheral Neuropathic PainSigns and Symptoms
- Registration Number
- ISRCTN80154838
- Lead Sponsor
- Sunovion Pharmaceuticals Europe Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 56
All subjects (males) will be in good health aged 18 - 55 years with no evidence of systemic disease and be able to comply with all aspects of the protocol and able to give written informed consent to participate in the study.
All subjects will not have, or have had a history of, clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological or other major disorders. They will not have, or have had a history of, drug or alcohol abuse and will not have participated in a clinical study with an investigational medicinal product (IMP) within 3 months of randomisation into the current study and will not have donated or lost > 500 mL of blood or blood products in the 3 months preceding the start of dosing.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety:<br>Parts 1 and 2: Adverse events (AEs), serious AEs (SAEs), vital signs, electrocardiogram (ECG) and ECG time intervals, clinical chemistry, haematology and urinalysis including biomarkers of renal function.<br>Pharmacodynamic:<br>Part 1 - ID capsaicin model: Subjective rating of pain using a visual analogue scale (VAS), area of punctate hyperalgesia, area of brush-evoked allodynia, area of vascular flare using laser Doppler flowmetry, intensity and area of cutaneous blood flow using laser Doppler flowmetry.<br><br>Part 2 - UVB model: Heat pain detection threshold (HPDT), heat pain tolerance threshold (HPTT), area of vascular flare using laser Doppler flowmetry, intensity and area of cutaneous blood flow using laser Doppler flowmetry.<br>Pharmacokinetic:<br>Parts 1 and 2: Plasma single dose PK of DSP-2230 and its metabolite
- Secondary Outcome Measures
Name Time Method o secondary outcome measures