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

NCT01258088 | Completed Phase 1 DMC

• 2 other identifiers: AN2728-PSR-104C3291010
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Plaque-type Psoriasis

Keywords

psoriasis

Outcome Measures

Primary Outcomes (1)

• Safety

  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).

  Up to 21 days

Secondary Outcomes (1)

• Pharmacokinetic profile

  16 Days Maximum

Study Arms (4)

Cohort 1: AN2728 Ointment

ACTIVE COMPARATOR

Drug: AN2728 Ointment

Cohort 1: AN2728 Vehicle

PLACEBO COMPARATOR

Drug: AN2728 Vehicle

Cohort 3: AN2728 Ointment

ACTIVE COMPARATOR

Drug: AN2728 Ointment

Cohort 3: AN2728 Vehicle

PLACEBO COMPARATOR

Drug: AN2728 Vehicle

Interventions

AN2728 Ointment DRUG

5mg/cm2, BID

Cohort 1: AN2728 Ointment; Cohort 3: AN2728 Ointment

AN2728 Vehicle DRUG

5mg/cm2 BID

Cohort 1: AN2728 Vehicle; Cohort 3: AN2728 Vehicle

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

CMAX (A Division of IDT Australia Ltd)

Adelaide, 5000, Australia

Location

MeSH Terms

Conditions

Psoriasis

Interventions

crisaborole

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

• Sepehr Shakib, MB BS, PhD

  Royal Adelaide Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 10, 2010
• Study Start: November 30, 2010
• Primary Completion: December 7, 2010
• Study Completion: December 7, 2010
• Last Updated: March 5, 2019

Record last verified: 2019-03

Locations

AU (1)