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

Last updated on November 18, 2019

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Study Location
Pfizer Investigational Site
Wythenshawe, Manchester, M23 9QZ United Kingdom
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00962663
Pfizer
Completed
Effects of ICA-105665 Using the Intradermal Capsaicin and Ultraviolet B (UV-B) Models in Healthy Male Subjects

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Descriptive Information
Brief Title  ICMJE Effects of ICA-105665 Using the Intradermal Capsaicin and Ultraviolet B (UV-B) Models in Healthy Male Subjects
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: ICA-105665
    Subjects randomized to receive ICA -105665 will receive 200 mg BID
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: ICA-105665
  • 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.
    Intervention: Drug: Ibuprofen
  • 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.
    Intervention: Drug: Placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2010)
25
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2009)
24
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion DateDecember 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00962663
Other Study ID Numbers  ICMJE ICA-105665-05
B5311006
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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