PainPhase 1NCT05181852
Study to Investigate the Pharmacodynamic Effects of IP2015 in Healthy Male Subjects Using the Intradermal Capsaicin Model
A Phase 1 study testing IP2015, dose 1, IP2015, dose 2 and Pregabalin in people with Pain, run by Initiator Pharma.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- IP2015, dose 1, IP2015, dose 2 and Pregabalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2022to 1 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomised, Double Blind, Placebo Controlled Study to Investigate the Pharmacodynamic Effects of IP2015 in Healthy Male Subjects Using the Intradermal Capsaicin Model
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
- Being tested
- IP2015, dose 1, IP2015, dose 2, Placebo, Pregabalin
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IP2015, dose 1Drug
Also called Test drug
Active
IP2015, dose 2Drug
Also called Test drug
Active
PlaceboDrug
Placebo
PregabalinDrug
Also called Comparator
Comparator
| Study group | Role | What they receive |
|---|---|---|
| IP2015_dose 1 | Experimental | Active Receives: Drug: IP2015, dose 1 |
| IP2015_dose 2 | Experimental | Active Receives: Drug: IP2015, dose 2 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Pregabalin | Active comparator | Comparator Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain related assessments of effect
The area of hyperalgesia
Measured: A 6 hours time interval after dosing
Secondary outcomes (4)
Pain related assessments of effect
Subjective rating of pain
Measured: A 6 hours time interval after dosing
Pain related assessments of effect
Pain VAS score of hyperalgesia
Measured: A 6 hours time interval after dosing
Pain related assessments of effect
Area and pain VAS score of brush-evoked allodynia
Measured: A 6 hours time interval after dosing
Pain related assessments of effect
Area of flare (AF)
Measured: A 6 hours time interval after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start5 Jan 2022 (estimated)
- Primary completion30 May 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Initiator Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandra Connell, MD, Principal investigator, MAC UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181852
- Sponsor's protocol ID
- IP2015CS03
- Status last verified
- Nov 2021
- First submitted
- 20 Nov 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo Controlled Study to Investigate the Pharmacodynamic Effects of IP2015 in Healthy Male Subjects Using the Intradermal Capsaicin Model
- ClinicalTrials.gov ID
- NCT05181852
- Acronym / sponsor ID
- IP2015CS03
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Initiator PharmaIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2022 (estimated)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IP2015_dose 1 | Experimental | Drug: IP2015, dose 1Active |
| IP2015_dose 2 | Experimental | Drug: IP2015, dose 2Active |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Pregabalin | Active comparator | Drug: PregabalinComparator |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IP2015, dose 1Also: Test drugActive | Drug | IP2015_dose 1 |
| IP2015, dose 2Also: Test drugActive | Drug | IP2015_dose 2 |
| PlaceboPlacebo | Drug | Placebo |
| PregabalinAlso: ComparatorComparator | Drug | Pregabalin |
Primary outcome
Pain related assessments of effect
Time frame: A 6 hours time interval after dosing
The area of hyperalgesia
4 secondary outcomes
Pain related assessments of effect
Time frame: A 6 hours time interval after dosing
Pain related assessments of effect
Time frame: A 6 hours time interval after dosing
Pain related assessments of effect
Time frame: A 6 hours time interval after dosing
Pain related assessments of effect
Time frame: A 6 hours time interval after dosing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Connell, MD principal investigator
MAC UK
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IP2015, dose 1, IP2015, dose 2 and Pregabalin in people with Pain, run by Initiator Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikael Thomsen (23276134, mt@initiatorpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain related assessments of effect (time frame: A 6 hours time interval after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.