CClinicalTrials.gg
Status unknownNCT05181852Updated Jan 6, 2022

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

A Phase 1 interventional study of IP2015, dose 1 and IP2015, dose 2 in Pain, sponsored by Initiator Pharma. Status unknown. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-06.

Sponsored by Initiator Pharma · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

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.

02

Conditions studied

  • Pain
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In context

Lead sponsor

Initiator Pharma is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    IP2015_dose 1

    Active

    Drug: IP2015, dose 1

  • Experimental
    IP2015_dose 2

    Active

    Drug: IP2015, dose 2

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

  • Active comparator
    Pregabalin

    Comparator

    Drug: Pregabalin

Interventions

  • DrugIP2015, dose 1

    Active

    Also known as: Test drug

  • DrugIP2015, dose 2

    Active

    Also known as: Test drug

  • DrugPlacebo

    Placebo

  • DrugPregabalin

    Comparator

    Also known as: Comparator

06

What researchers measure

Primary outcomes

  1. Pain related assessments of effect

    The area of hyperalgesia

    Time frame: A 6 hours time interval after dosing

Secondary outcomes

  1. Pain related assessments of effect

    Subjective rating of pain

    Time frame: A 6 hours time interval after dosing

  2. Pain related assessments of effect

    Pain VAS score of hyperalgesia

    Time frame: A 6 hours time interval after dosing

  3. Pain related assessments of effect

    Area and pain VAS score of brush-evoked allodynia

    Time frame: A 6 hours time interval after dosing

  4. Pain related assessments of effect

    Area of flare (AF)

    Time frame: A 6 hours time interval after dosing

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05181852
Lead sponsor
Initiator Pharma
Responsible party
Sponsor
First posted
Jan 6, 2022
Start date
Jan 5, 2022 (estimated)
Primary completion
May 30, 2022 (estimated)
Completion
Jul 1, 2022 (estimated)
Last update
Jan 6, 2022

Study contacts

Mikael Thomsen
Contact
mt@initiatorpharma.com
23276134
Claus Olesen
Contact
ceo@initiatorpharma.com
61260035
Sandra Connell, MD
principal investigator · MAC UK

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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