Effects of ICA-105665 Using the Intradermal Capsaicin and Ultraviolet B (UV-B) Models in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00962663
First received: August 19, 2009
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

The purpose of this study is; to determine the pharmacodynamic (PD) effects of ICA-105665 using the intradermal (ID) capsaicin model in healthy male subjects, and to investigate the effect of ICA-105665 on inflammatory hyperalgesia using the ultraviolet B (UV-B) model in healthy male subjects.


Condition Intervention Phase
Healthy
Drug: ICA-105665
Drug: Ibuprofen
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomized, Placebo-Controlled, 3-way Crossover Study to Investigate the Pharmacodynamic Effects of ICA-105665 Using the Intradermal Capsaicin and UV-B Models in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Capsaicin: Visual Analogue Scale, hyperalgesia, allodynia, laser Doppler blood flow. UV-B pain assessments: Heat pain detection threshold, Heat pain tolerance threshold (HPTT), Laser Doppler blood flow (intensity and area), Skin temperature. [ Time Frame: Capsaicin - Time 0, to 2 hours after injection. UV-B Pain: 2 hours post ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • UV-B: Heat pain,Laser Doppler Blood Flow [ Time Frame: 24 hours after irradiation ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: August 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ICA-105665
Three study drug treatments will be used: ICA-105665, ibuprofen, and placebo (for both ICA-105665 and Ibuprofen). The order of study drug treatment given to each subject during each specified treatment period is determined at randomization.
Drug: ICA-105665
Subjects randomized to receive ICA -105665 will receive 200 mg BID
Active Comparator: Ibuprofen
Three study drug treatments will be used: ICA-105665, ibuprofen, and placebo (for both ICA-105665 and Ibuprofen). The order of study drug treatment given to each subject during each specified treatment period is determined at randomization.
Drug: Ibuprofen
Subjects randomized to receive Ibuprofen will receive placebo to ICA-105665 at all scheduled dosing times on Days 1 to 4 and a single dose of 800 mg Ibuprofen on the morning of Day 4.
Other Name: Cuprofen
Placebo Comparator: Placebo
Three study drug treatments will be used: ICA-105665, ibuprofen, and placebo (for both ICA-105665 and Ibuprofen). The order of study drug treatment given to each subject during each specified treatment period is determined at randomization.
Drug: Placebo

Subjects randomized to receive placebo will receive placebo to ICA

-105665 at all scheduled dosing times on Days 1 to 4 and placebo to Ibuprofen on the morning of Day 4.

Other Name: orange Syrup BP

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males aged 18 to 55 years (inclusive).
  • Body mass index (BMI) of 18 to 30 kg/m2.
  • Non-smokers and smokers of up to 5 cigarettes or equivalent per day.
  • Must be able to abstain from smoking during residential periods.
  • Demonstration of positive hyperalgesia as defined by an area of hyperalgesia = 15 cm2 15 minutes after ID administration of 100 µg capsaicin.
  • Demonstration of negative hyperalgesia as defined by an area of hyperalgesia < 5 cm2 15 minutes after ID administration of capsaicin vehicle.
  • Subject 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:

  • Subject has had a clinically significant illness in the 4 weeks before screening.
  • Use of prescribed medications and herbal supplements in the 7 days prior to dosing or over the counter preparations, including multivitamins and paracetamol, in the 48 h before dosing.
  • Subject has a significant history of drug/solvent abuse (within 2 years prior to Day 1), or a positive drugs of abuse test at screening.
  • Subject with a history of alcohol abuse or currently drinks in excess of 28 units per week (males), or has a positive breath alcohol test at the Screening visit or on Day 1.
  • Subject has a Heat pain tolerance threshold (HPTT) of = 50°C at screening.
  • Subjects who do not develop erythema at the highest intensity of UV-B light used to establish Minimum erythema dose (MED).
  • Known allergy or intolerance to capsaicin or hot peppers.
  • Subjects who have any skin trauma, scars or other skin disorder or tattoos on their forearms or on the front of their thighs.
  • Subject with active chronic pain conditions or a history of chronic pain conditions.
  • Any condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs.
  • Previous ingestion of ICA-105665.
  • Considering or scheduled to undergo any surgical procedure during the duration of the study.
  • Prolonged QT/QTc interval (repeatedly = 450 msec). Received any agent known to alter hepatic or renal clearance (e.g., erythromycin, cimetidine, barbiturates, phenothiazines, clarithromycin, troleandomycin, ketoconazole, miconazole, fluconazole, itraconazole, etc.) for a period of 30 days prior to Day 1.
  • History of risk factors for Torsades de Pointes (family history of long QT syndrome, heart failure, hypokalemia).
  • Subject is unable to tolerate being blindfolded.
  • Subject has participated in a clinical study involving capsaicin within 1 year of the Screening visit.
  • Subject has a history of skin cancer.
  • Subject has a clinically significant history of anemia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962663

Locations
United Kingdom
Pfizer Investigational Site
Unknown, Manchester, United Kingdom, M15 6SH
Pfizer Investigational Site
Wythenshawe, Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00962663     History of Changes
Other Study ID Numbers: ICA-105665-05, B5311006
Study First Received: August 19, 2009
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Capsaicin
Ibuprofen
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 14, 2014