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

NCT00962663 | Completed Phase 1

• 2 other identifiers: ICA-105665-05B5311006
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  Capsaicin - Time 0, to 2 hours after injection. UV-B Pain: 2 hours post

Secondary Outcomes (1)

• UV-B: Heat pain,Laser Doppler Blood Flow

  24 hours after irradiation

Study Arms (3)

ICA-105665

EXPERIMENTAL

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

Ibuprofen

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

ICA-105665 DRUG

Subjects randomized to receive ICA -105665 will receive 200 mg BID

ICA-105665

Ibuprofen DRUG

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.

Also known as: Cuprofen

Ibuprofen

Placebo DRUG

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.

Also known as: orange Syrup BP

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Investigational Site

Wythenshawe, Manchester, M23 9QZ, United Kingdom

Location

Pfizer Investigational Site

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2009
• First Posted: August 20, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 28, 2012

Record last verified: 2012-09

Locations

GB (1)