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
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.
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.
Exclusion Criteria:
Active
Drug: IP2015, dose 1
Active
Drug: IP2015, dose 2
Placebo
Drug: Placebo
Comparator
Drug: Pregabalin
Active
Also known as: Test drug
Active
Also known as: Test drug
Placebo
Comparator
Also known as: Comparator
Pain related assessments of effect
The area of hyperalgesia
Time frame: A 6 hours time interval after dosing
Pain related assessments of effect
Subjective rating of pain
Time frame: A 6 hours time interval after dosing
Pain related assessments of effect
Pain VAS score of hyperalgesia
Time frame: A 6 hours time interval after dosing
Pain related assessments of effect
Area and pain VAS score of brush-evoked allodynia
Time frame: A 6 hours time interval after dosing
Pain related assessments of effect
Area of flare (AF)
Time frame: A 6 hours time interval after dosing
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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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Initiator Pharma