CompletedPhase 1

Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis

United States59 participantsStarted 2002-11

Plain-language summary

This study was conducted in subjects with psoriasis to evaluate drug activity in this patient population by analysis of changes in psoriatic lesion biopsy characteristics. This subject population was selected to evaluate potentially relevant biological activity of CP-690,550 as well as assessing safety and pharmacokinetics.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and/or female subjects between the ages of 18 and 65 years, inclusive, with active psoriasis lesion(s). * Subjects should be healthy with the exception of psoriasis, where healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination. Blood pressure must be \< 140/89. Body Mass Index (BMI) between 18-36 kg/m2, inclusive; and a total body weight \>50 kg (110 lbs) * The following laboratory variables must be no more than 10% below the lower limit of the normal reference range: RBC, hemoglobin, hematocrit, WBC, absolute neutrophil count. The absolute lymphocyte count must be greater than or equal to the lower limit of the reference range. Values for AST, ALT, bilirubin and alkaline phosphatase must be no more than 10% above the upper limit of the normal reference range. Values for total cholesterol and LDL must be no more than 20% above the upper limit of the normal reference range except for subjects being treated for hyperlipidemia. Normal glomerular filtration rate (\> 80 mL/min). Exclusion Criteria: * Subjects with evidence or history of clinically significant hematological, renal, urological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disorder. * Subjects with controlled essential hypertension and/or hyperlipidemia may be eligible for the study provided that any medications that are administered. * Screening 12-lead ECG demonstrating a…

What they're measuring

Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1

Timeframe: 23 hours (hrs) prior to morning dose on Day 1 (Baseline for HPD 1), 1 hour (hr) post morning dose on Day 1

Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1

Timeframe: 22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 1

Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1

Timeframe: 20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 1

Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1

Timeframe: 16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 1

Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1

Timeframe: 12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 1

Change From Baseline in QT Interval at 16 Hour Post Morning Dose (HPD 16) on Day 1

Timeframe: 8 hrs prior to morning dose on Day 1 (Baseline for HPD 16), 16 hrs post morning dose on Day 1

Trial details

NCT IDNCT01736696

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2004-04

Results submitted2012-12-06

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