NCT05181852

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Initiator Pharma · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	IP2015, dose 1	Active
DRUG	IP2015, dose 2	Active
DRUG	Placebo	Placebo
DRUG	Pregabalin	Comparator

Timeline

• Start date: 2022-01-05
• Primary completion: 2022-05-30
• Completion: 2022-07-01
• First posted: 2022-01-06
• Last updated: 2022-01-06