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Safety Study of Ointment for the Treatment of Plaque-type Psoriasis (AN2728-PSR-104)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01258088
Recruitment Status : Completed
First Posted : December 10, 2010
Last Update Posted : March 5, 2019
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE December 8, 2010
First Posted Date  ICMJE December 10, 2010
Last Update Posted Date March 5, 2019
Actual Study Start Date  ICMJE November 30, 2010
Actual Primary Completion Date December 7, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2010)
Safety [ Time Frame: Up to 21 days ]
12-lead ECG, clinical laboratory tests, urinalysis, spontaneous/elicited adverse event (AE) reporting, local site reactions, physical exam and vital signs (blood pressure, heart rate).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01258088 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2010)
Pharmacokinetic profile [ Time Frame: 16 Days Maximum ]
Non-compartmental analysis of classic PK parameters: AUC(0-t), Cmax, Tmax, terminal t-1/2 (computed if data from majority of subjects permit) of AN2728, on Days 1 and 7 (or last day of administration). Trough plasma concentrations at the end of the dosing interval (Ctrough) collected at pre-morning dose.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
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 Summary The purpose of this study is to determine how much drug is absorbed throughout the body after being applied to the skin.
Detailed Description Not 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 Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2010)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 7, 2010
Actual Primary Completion Date December 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 Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer Call Center Pfizer
Principal Investigator: Sepehr Shakib, MB BS, PhD Royal Adelaide Hospital
PRS Account Pfizer
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP