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Safety Study of Ointment for the Treatment of Plaque-type Psoriasis

Last updated on November 10, 2019

FOR MORE INFORMATION
Study Location
CMAX (A Division of IDT Australia Ltd)
Adelaide, , 5000 Australia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Plaque-Type Psoriasis
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

- White males, 18 - 55 years (inclusive) of age at the time of randomization.

- Body weight between 60-90 kg (Body Mass Index [BMI] between 19 and 30 kg/m2
[inclusive]).

- Willing and able to comply with study instructions and commit to all follow-up
visits.

- Have adequate venous access to permit repeated PK sampling.

- Ability to understand, agree to and sign the study Informed Consent Form (ICF) prior
to initiation of any protocol-related procedures.

- Non-smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine
patches, etc., for 6 months prior to the administration of the study medication).

For psoriasis patients (in addition to the above criteria):

- Clinical diagnosis of stable plaque-type psoriasis with active plaques involving
5%-20% of total BSA excluding face, scalp and groin.

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

- History of serious adverse reactions or hypersensitivity to any drug; or known
allergy to any of the test product(s) or any components in the test product(s) or
history of hypersensitivity; or allergic reactions to any of the study preparations
as described in the Investigator's Brochure.

- Any clinically significant central nervous system (e.g., seizures), cardiac,
pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of
such conditions that, in the opinion of the Investigator may place the subject at an
unacceptable risk as a participant in this trial or may interfere with the
distribution, metabolism or excretion of drugs.

- Abnormal physical findings of clinical significance at the Screening examination or
Baseline which would interfere with the objectives of the study.

- History of orthostatic hypotension (an increase in HR ?20 bpm accompanied by a ?20 mm
Hg drop in SBP and/or ?10 mm Hg drop in DBP) present at Screening.

- Clinically significant abnormal laboratory values (as determined by the Investigator)
at the Screening evaluation.

- Presence or history of allergies requiring acute or chronic treatment (except
seasonal allergic rhinitis).

- 12-lead ECG obtained at Screening with: PR >240 msec, QRS >110 msec and QTc >450
msec, bradycardia ( Screening ECG, or any other changes on the Screening ECG that would interfere with
measurement of the QT interval.

- Major surgical interventions within 6 months of the study.

- Has a positive pre-study Hepatitis B surface antigen; positive Hepatitis C (HCV)
antibody or detectable HCV ribonucleic acid (RNA); or positive HIV antibody result.

- Use of prescription or non-prescription drugs, including vitamin supplements, herbal
and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to
the first dose of study medication, or use of St. John's Wort within 28 days prior to
the first dose of study medication. However, the Investigator and study team can
review medication use on a case by case basis to determine if its use would
compromise subject safety or interfere with study procedures or data interpretation.
By exception, the subject may take paracetamol or acetaminophen (?2 g/day) or
ibuprofen (?1600 mg/day) up to 48 h prior to the first dose of study medication.

- Has a history of regular alcohol consumption averaging >14 drinks/week (1 drink [100
mL wine or 280 mL standard strength beer or 30 mL of 80 proof distilled spirits])
within 6 months of the Screening visit.

- Loss of 500 mL blood or more during the 3 month period before the study, e.g., blood
donor.

- People that follow vegetarian or vegan diets.

- Symptoms of a significant somatic or mental illness in the four week period preceding
drug administration.

- History of drug abuse or dependence within 12 months of the study.

- Positive pre-study urine drug and alcohol screen. A minimum list of drugs that will
be screened for include benzodiazepines, opiates, methadone metabolite (EDDP),
sympathomimetic amines, cannabinoids, barbiturates, cocaine, and ethanol. (Suspected
false positive results may be repeated at the discretion of the Investigator.)

- Concurrent or recent (within 60 days) participation in another drug or device
research study.

- Considered by the Investigator to be unsuitable candidate for this study. Use of
AN2728 in a previous clinical trial.

For psoriasis patients (in addition to the above exclusion criteria):

- Spontaneously improving or rapidly deteriorating psoriatic plaques or
pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis.

- Currently have drug-induced psoriasis (new onset or exacerbation of psoriasis from
beta blockers, calcium channel blockers, or lithium).

- Other serious skin disorder(s).

- Use of non-biologic systemic anti-psoriatic therapy (e.g., corticosteroids, PUVA,
UVB, retinoids, methotrexate, cyclosporine, other immunosuppressive agents) or
biologic therapy (e.g., alefacept, etanercept, adalimumab, ustekinumab) within four
weeks prior to enrollment or concurrently during the study.

- Use of topical treatments that have a known beneficial effect on psoriasis, including
but not limited to corticosteroids, retinoids, vitamin D derivatives, tar or
anthralin, within the past two weeks prior to enrollment or concurrently during the
study.

- Systemic medications for other medical conditions that are known to affect psoriasis
(e.g., lithium, beta adrenergic blockers) within the past four weeks prior to
enrollment or concurrently during the study.

- Use of emollients/moisturizers on area(s) to be treated within two days prior to
enrollment.

NCT01258088
Pfizer
Completed
Safety Study of Ointment for the Treatment of Plaque-type Psoriasis

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Descriptive Information
Brief Title  ICMJE Safety Study of Ointment for the Treatment of Plaque-type Psoriasis
Official Title  ICMJE A Randomized, Double-blind, Vehicle-controlled, Multiple Cohort Study To Determine The Safety, Tolerability, And Pharmacokinetic Profile Of An2728 Ointment B, 2% In Healthy Volunteers And Patients With Mild-to-moderate Plaque-type Psoriasis
Brief SummaryThe purpose of this study is to determine how much drug is absorbed throughout the body after being applied to the skin.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Plaque-type Psoriasis
Intervention  ICMJE
  • Drug: AN2728 Ointment
    5mg/cm2, BID
  • Drug: AN2728 Vehicle
    5mg/cm2 BID
Study Arms  ICMJE
  • Active Comparator: Cohort 1: AN2728 Ointment
    Intervention: Drug: AN2728 Ointment
  • Placebo Comparator: Cohort 1: AN2728 Vehicle
    Intervention: Drug: AN2728 Vehicle
  • Active Comparator: Cohort 3: AN2728 Ointment
    Intervention: Drug: AN2728 Ointment
  • Placebo Comparator: Cohort 3: AN2728 Vehicle
    Intervention: Drug: AN2728 Vehicle
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: December 9, 2010)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 7, 2010
Actual Primary Completion DateDecember 7, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • White males, 18 - 55 years (inclusive) of age at the time of randomization.
  • Body weight between 60-90 kg (Body Mass Index [BMI] between 19 and 30 kg/m2 [inclusive]).
  • Willing and able to comply with study instructions and commit to all follow-up visits.
  • Have adequate venous access to permit repeated PK sampling.
  • Ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol-related procedures.
  • Non-smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the administration of the study medication).

For psoriasis patients (in addition to the above criteria):

  • Clinical diagnosis of stable plaque-type psoriasis with active plaques involving 5%-20% of total BSA excluding face, scalp and groin.

Exclusion Criteria:

  • History of serious adverse reactions or hypersensitivity to any drug; or known allergy to any of the test product(s) or any components in the test product(s) or history of hypersensitivity; or allergic reactions to any of the study preparations as described in the Investigator's Brochure.
  • Any clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such conditions that, in the opinion of the Investigator may place the subject at an unacceptable risk as a participant in this trial or may interfere with the distribution, metabolism or excretion of drugs.
  • Abnormal physical findings of clinical significance at the Screening examination or Baseline which would interfere with the objectives of the study.
  • History of orthostatic hypotension (an increase in HR ?20 bpm accompanied by a ?20 mm Hg drop in SBP and/or ?10 mm Hg drop in DBP) present at Screening.
  • Clinically significant abnormal laboratory values (as determined by the Investigator) at the Screening evaluation.
  • Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
  • 12-lead ECG obtained at Screening with: PR >240 msec, QRS >110 msec and QTc >450 msec, bradycardia (<50 bpm) or clinically significant minor ST wave changes on the Screening ECG, or any other changes on the Screening ECG that would interfere with measurement of the QT interval.
  • Major surgical interventions within 6 months of the study.
  • Has a positive pre-study Hepatitis B surface antigen; positive Hepatitis C (HCV) antibody or detectable HCV ribonucleic acid (RNA); or positive HIV antibody result.
  • Use of prescription or non-prescription drugs, including vitamin supplements, herbal and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, or use of St. John's Wort within 28 days prior to the first dose of study medication. However, the Investigator and study team can review medication use on a case by case basis to determine if its use would compromise subject safety or interfere with study procedures or data interpretation. By exception, the subject may take paracetamol or acetaminophen (?2 g/day) or ibuprofen (?1600 mg/day) up to 48 h prior to the first dose of study medication.
  • Has a history of regular alcohol consumption averaging >14 drinks/week (1 drink [100 mL wine or 280 mL standard strength beer or 30 mL of 80 proof distilled spirits]) within 6 months of the Screening visit.
  • Loss of 500 mL blood or more during the 3 month period before the study, e.g., blood donor.
  • People that follow vegetarian or vegan diets.
  • Symptoms of a significant somatic or mental illness in the four week period preceding drug administration.
  • History of drug abuse or dependence within 12 months of the study.
  • Positive pre-study urine drug and alcohol screen. A minimum list of drugs that will be screened for include benzodiazepines, opiates, methadone metabolite (EDDP), sympathomimetic amines, cannabinoids, barbiturates, cocaine, and ethanol. (Suspected false positive results may be repeated at the discretion of the Investigator.)
  • Concurrent or recent (within 60 days) participation in another drug or device research study.
  • Considered by the Investigator to be unsuitable candidate for this study. Use of AN2728 in a previous clinical trial.

For psoriasis patients (in addition to the above exclusion criteria):

  • Spontaneously improving or rapidly deteriorating psoriatic plaques or pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis.
  • Currently have drug-induced psoriasis (new onset or exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
  • Other serious skin disorder(s).
  • Use of non-biologic systemic anti-psoriatic therapy (e.g., corticosteroids, PUVA, UVB, retinoids, methotrexate, cyclosporine, other immunosuppressive agents) or biologic therapy (e.g., alefacept, etanercept, adalimumab, ustekinumab) within four weeks prior to enrollment or concurrently during the study.
  • Use of topical treatments that have a known beneficial effect on psoriasis, including but not limited to corticosteroids, retinoids, vitamin D derivatives, tar or anthralin, within the past two weeks prior to enrollment or concurrently during the study.
  • Systemic medications for other medical conditions that are known to affect psoriasis (e.g., lithium, beta adrenergic blockers) within the past four weeks prior to enrollment or concurrently during the study.
  • Use of emollients/moisturizers on area(s) to be treated within two days prior to enrollment.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
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 Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01258088
Other Study ID Numbers  ICMJE AN2728-PSR-104
C3291010 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeYes
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
Principal Investigator:Sepehr Shakib, MB BS, PhDRoyal Adelaide Hospital
PRS AccountPfizer
Verification DateMarch 2019

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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