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

NCT05181852 | Unknown Phase 1

• 1 other identifier: IP2015CS03
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Pain related assessments of effect

  The area of hyperalgesia

  A 6 hours time interval after dosing

Secondary Outcomes (4)

• Pain related assessments of effect

  A 6 hours time interval after dosing

• Pain related assessments of effect

  A 6 hours time interval after dosing

• Pain related assessments of effect

  A 6 hours time interval after dosing

• Pain related assessments of effect

  A 6 hours time interval after dosing

Study Arms (4)

IP2015_dose 1

EXPERIMENTAL

Active

Drug: IP2015, dose 1

IP2015_dose 2

EXPERIMENTAL

Active

Drug: IP2015, dose 2

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Pregabalin

ACTIVE COMPARATOR

Comparator

Drug: Pregabalin

Interventions

IP2015, dose 1 DRUG

Active

Also known as: Test drug

IP2015_dose 1

IP2015, dose 2 DRUG

Active

Also known as: Test drug

IP2015_dose 2

Placebo DRUG

Placebo

Placebo

Pregabalin DRUG

Comparator

Also known as: Comparator

Pregabalin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Initiator Pharma: lead

MeSH Terms

Conditions

Pain

Interventions

Drug Evaluation; Pregabalin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sandra Connell, MD

  MAC UK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikael Thomsen

CONTACT

23276134; mt@initiatorpharma.com

Claus Olesen

CONTACT

61260035; ceo@initiatorpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2021
• First Posted: January 6, 2022
• Study Start: January 5, 2022
• Primary Completion: May 30, 2022
• Study Completion: July 1, 2022
• Last Updated: January 6, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share