Study to Investigate the Pharmacodynamic Effects of IP2015 in Healthy Male Subjects Using the Intradermal Capsaicin Model
Study Details
Study Description
Brief Summary
This is a Phase I, randomised, double-blind, placebo-controlled, 4-way crossover study to investigate the PD effects, safety, tolerability and PK/PD correlation of two single oral dose levels of IP2015 compared to 300 mg pregabalin and placebo in healthy male subjects using the ID capsaicin model.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IP2015_dose 1 Active |
Drug: IP2015, dose 1
Active
Other Names:
|
| Experimental: IP2015_dose 2 Active |
Drug: IP2015, dose 2
Active
Other Names:
|
| Placebo Comparator: Placebo Placebo |
Drug: Placebo
Placebo
|
| Active Comparator: Pregabalin Comparator |
Drug: Pregabalin
Comparator
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pain related assessments of effect [A 6 hours time interval after dosing]
The area of hyperalgesia
Secondary Outcome Measures
- Pain related assessments of effect [A 6 hours time interval after dosing]
Subjective rating of pain
- Pain related assessments of effect [A 6 hours time interval after dosing]
Pain VAS score of hyperalgesia
- Pain related assessments of effect [A 6 hours time interval after dosing]
Area and pain VAS score of brush-evoked allodynia
- Pain related assessments of effect [A 6 hours time interval after dosing]
Area of flare (AF)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is male, with a skin type compatible with capsaicin measurements.
-
Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, clinical laboratory evaluations.
-
Subject must be in good general health with a skin type compatible with the measures, and without significant skin allergies, pigmentary disorders, or any active dermatological conditions that might interfere with the conduct of the study.
Exclusion Criteria:
-
Any significant CNS, cardiac, pulmonary, metabolic, renal, hepatic (including Gilbert's syndrome), gastrointestinal (GI) or psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of the Investigator, may place the subject at an unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion (ADME) of drugs, or with the completion of treatment according to this Protocol.
-
Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, respiratory, GI, hepatic, or renal disorder).
-
Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs, or physical findings at Screening. In case of uncertain or questionable results, tests performed during Screening may be repeated to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Initiator Pharma
Investigators
- Principal Investigator: Sandra Connell, MD, MAC UK
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IP2015CS03