A Randomised, Double Blind, Placebo Controlled Study to Investigate the Pharmacodynamic Effects of IP2015 in Healthy Male Subjects Using the Intradermal Capsaicin Model

Initiator Pharma0 sites24 target enrollmentJanuary 5, 2022

ConditionsPain

InterventionsIP2015, dose 1 IP2015, dose 2 Placebo Pregabalin

DrugsIP2015, dose 1 IP2015, dose 2 Placebo Pregabalin

Overview

Phase: Phase 1
Intervention: IP2015, dose 1
Conditions: Pain
Sponsor: Initiator Pharma
Enrollment: 24
Primary Endpoint: Pain related assessments of effect
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 5, 2022

End Date

July 1, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Initiator Pharma

Responsible Party

Sponsor

Eligibility 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.