Plaque-type PsoriasisPhase 1AN2728-PSR-104NCT01258088
Safety Study of Ointment for the Treatment of Plaque-type Psoriasis
A Phase 1 study testing AN2728 Ointment in people with Plaque-type Psoriasis, run by Pfizer at 1 site in Australia.
Trial summary
The purpose of this study is to determine how much drug is absorbed throughout the body after being applied to the skin. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Plaque-type Psoriasis
- What is being tested?
- AN2728 Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Nov 2010to 7 Dec 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- AN2728 Ointment, AN2728 Vehicle
- Keywords
- psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AN2728 OintmentDrug
5mg/cm2, BID
AN2728 VehicleDrug
5mg/cm2 BID
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: AN2728 Ointment | Active comparator | Not described Receives: Drug: AN2728 Ointment |
| Cohort 1: AN2728 Vehicle | Placebo comparator | Not described Receives: Drug: AN2728 Vehicle |
| Cohort 3: AN2728 Ointment | Active comparator | Not described Receives: Drug: AN2728 Ointment |
| Cohort 3: AN2728 Vehicle | Placebo comparator | Not described Receives: Drug: AN2728 Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 21 days
Secondary outcomes (1)
Pharmacokinetic profile
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.
Measured: 16 Days Maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study start30 Nov 2010
- Primary completion7 Dec 2010
- Study completion7 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque-type PsoriasisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, PfizerSepehr Shakib, MB BS, PhD, Principal investigator, Royal Adelaide Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258088
- Sponsor's protocol ID
- AN2728-PSR-104
- Other IDs
- C3291010
- Acronym
- AN2728-PSR-104
- Status last verified
- Mar 2019
- First submitted
- 8 Dec 2010
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01258088
- Acronym / sponsor ID
- AN2728-PSR-104 / AN2728-PSR-104
- Conditions
- Plaque-type Psoriasis
- Keywords
- psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2010 (actual)
- Primary completion
- 7 Dec 2010 (actual)
- Study completion
- 7 Dec 2010 (actual)
- First posted
- 10 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine how much drug is absorbed throughout the body after being applied to the skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AN2728 Ointment5mg/cm2, BID | Drug | Cohort 1: AN2728 Ointment, Cohort 3: AN2728 Ointment |
| AN2728 Vehicle5mg/cm2 BID | Drug | Cohort 1: AN2728 Vehicle, Cohort 3: AN2728 Vehicle |
Primary outcome
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).
1 secondary outcome
Pharmacokinetic profile
Time frame: 16 Days Maximum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Sepehr Shakib, MB BS, PhD principal investigator
Royal Adelaide Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AN2728 Ointment in people with Plaque-type Psoriasis, run by Pfizer at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.