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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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 August 19, 2014