Study to Investigate the Pharmacodynamic Effects of IP2015 in Healthy Male Subjects Using the Intradermal Capsaicin Model

Phase 1

• Conditions: Pain
• Interventions: Drug: IP2015, dose 1; Drug: IP2015, dose 2; Drug: Placebo; Drug: Pregabalin

• Registration Number: NCT05181852
• Lead Sponsor: Initiator Pharma

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-20
• Study Start: 2022-01-05
• Study First Submitted QC: 2022-01-05
• Last Update Submitted: 2022-01-05
• Study First Posted: 2022-01-06
• Last Update Posted: 2022-01-06
• Primary Completion: 2022-05-30
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IP2015_dose 1	IP2015, dose 1	Active
IP2015_dose 2	IP2015, dose 2	Active
Placebo	Placebo	Placebo
Pregabalin	Pregabalin	Comparator

Primary Outcome Measures

Name	Time	Method
Pain related assessments of effect	A 6 hours time interval after dosing	The area of hyperalgesia

Secondary Outcome Measures

Name	Time	Method
Pain related assessments of effect	A 6 hours time interval after dosing	Area of flare (AF)