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

This study has been completed.
Sponsor:
Information provided by:
Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01258088
First received: December 8, 2010
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

The purpose of this study is to determine how much drug is absorbed throughout the body after being applied to the skin.


Condition Intervention Phase
Plaque-Type Psoriasis
Drug: AN2728 Ointment
Drug: AN2728 Vehicle
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Anacor Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: Up to 21 days ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Pharmacokinetic profile [ Time Frame: 16 Days Maximum ] [ Designated as safety issue: No ]
    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.


Enrollment: 16
Study Start Date: November 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort 1: AN2728 Ointment Drug: AN2728 Ointment
5mg/cm2, BID
Placebo Comparator: Cohort 1: AN2728 Vehicle Drug: AN2728 Vehicle
5mg/cm2 BID
Active Comparator: Cohort 3: AN2728 Ointment Drug: AN2728 Ointment
5mg/cm2, BID
Placebo Comparator: Cohort 3: AN2728 Vehicle Drug: AN2728 Vehicle
5mg/cm2 BID

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01258088

Locations
Australia
CMAX (A Division of IDT Australia Ltd)
Adelaide, Australia, 5000
Sponsors and Collaborators
Anacor Pharmaceuticals, Inc.
Investigators
Principal Investigator: Sepehr Shakib, MB BS, PhD Royal Adelaide Hospital
  More Information

No publications provided

Responsible Party: Lee Zane, MD, MAS, Anacor Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01258088     History of Changes
Other Study ID Numbers: AN2728-PSR-104
Study First Received: December 8, 2010
Last Updated: December 9, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee

Keywords provided by Anacor Pharmaceuticals, Inc.:
psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on October 02, 2014