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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05181852
• Other study ID #: IP2015CS03
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 5, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: November 2021
• Source: Initiator Pharma
• Contact: Mikael Thomsen
• Phone: 23276134
• Email: mt[@]initiatorpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: July 1, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• IP2015, dose 1
Active
• IP2015, dose 2
Active
• Placebo
Placebo
• Pregabalin
Comparator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Initiator Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain related assessments of effect	The area of hyperalgesia	A 6 hours time interval after dosing
Secondary	Pain related assessments of effect	Subjective rating of pain	A 6 hours time interval after dosing
Secondary	Pain related assessments of effect	Pain VAS score of hyperalgesia	A 6 hours time interval after dosing
Secondary	Pain related assessments of effect	Area and pain VAS score of brush-evoked allodynia	A 6 hours time interval after dosing
Secondary	Pain related assessments of effect	Area of flare (AF)	A 6 hours time interval after dosing