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

NCT ID: NCT05181852

Last Updated: 2022-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-05
• Study Completion Date: 2022-07-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IP2015_dose 1

Active

Group Type: EXPERIMENTAL

IP2015, dose 1

Intervention Type: DRUG

Active

IP2015_dose 2

Active

Group Type: EXPERIMENTAL

IP2015, dose 2

Intervention Type: DRUG

Active

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Pregabalin

Comparator

Group Type: ACTIVE_COMPARATOR

Pregabalin

Intervention Type: DRUG

Comparator

Interventions

IP2015, dose 1

Active

Intervention Type: DRUG

IP2015, dose 2

Active

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Pregabalin

Comparator

Intervention Type: DRUG

Other Intervention Names

Test drug; Test drug; Comparator

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Initiator Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra Connell, MD

Role: PRINCIPAL_INVESTIGATOR

MAC UK

Central Contacts

Mikael Thomsen

Role: CONTACT

mt@initiatorpharma.com

23276134

Claus Olesen

Role: CONTACT

ceo@initiatorpharma.com

61260035

Other Identifiers

IP2015CS03

Identifier Type: -

Identifier Source: org_study_id