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

NCT05181852 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-01-06

No results posted yet for this study

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

Interventions

DRUG

IP2015, dose 1

Active

DRUG

IP2015, dose 2

Active

DRUG

Placebo

Placebo

DRUG

Pregabalin

Comparator

Sponsors & Collaborators

  • Initiator Pharma

    lead INDUSTRY

Principal Investigators

  • Sandra Connell, MD · MAC UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-05
Primary Completion
2022-05-30
Completion
2022-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05181852 on ClinicalTrials.gov