Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis

NCT ID: NCT01736696

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2004-04-30

Brief 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.

Conditions

Psoriasis; Immunomodulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

5 mg BID

5 mg BID for 13 days and once on Day 14

Group Type: EXPERIMENTAL

tofacitinib

Intervention Type: DRUG

5 mg BID For 13 days and once on Day 14

10 mg BID

10 mg BID for13 days and once on Day 14\*

Group Type: EXPERIMENTAL

tofacitinib

Intervention Type: DRUG

10 mg BID for 13 days and once on Day 14\*

20 mg BID

20 mg BID for 13 days and once on Day 14

Group Type: EXPERIMENTAL

tofacitinib

Intervention Type: DRUG

20 mg BID for 13 days and once on Day 14

30 mg BID

30 mg BID for 13 days and once on Day 14

Group Type: EXPERIMENTAL

tofacitinib

Intervention Type: DRUG

30 mg BID for 13 days and once on Day 14

60 mg QD

60 mg QD for 14 days

Group Type: EXPERIMENTAL

tofacitinib

Intervention Type: DRUG

60 mg tablet once a day (QD) for 14 days

50 mg BID

50 mg BID x 13 days and once on day 14

Group Type: EXPERIMENTAL

tofacitinib

Intervention Type: DRUG

50 mg tablets two times a day (BID) for 13 days and once on day 14

Interventions

tofacitinib

5 mg BID For 13 days and once on Day 14

Intervention Type: DRUG

tofacitinib

10 mg BID for 13 days and once on Day 14\*

Intervention Type: DRUG

tofacitinib

20 mg BID for 13 days and once on Day 14

Intervention Type: DRUG

tofacitinib

30 mg BID for 13 days and once on Day 14

Intervention Type: DRUG

tofacitinib

60 mg tablet once a day (QD) for 14 days

Intervention Type: DRUG

tofacitinib

50 mg tablets two times a day (BID) for 13 days and once on day 14

Intervention Type: DRUG

Eligibility Criteria

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 at least one of the following: heart rate > 100 bpm, QRS >120 msec, QTc > 430 msec (males), QTc > 450 msec (females) or PR > 220 msec.
• Abnormal chest radiographs including, but not limited to, evidence of past or present tuberculosis infection. History of tuberculosis without treatment and/or positive tuberculin reaction without known vaccination with BCG.
• Subjects with a history of tumors with the exception of adequately treated basal cell carcinoma of the skin.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

Little Rock, Arkansas, United States

Countries

United States

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921003&StudyName=Multiple%20Dose%20Escalation%20Study%20In%20Medically%20Stable%20Subjects%20With%20Psoriasis%20

To obtain contact information for a study center near you, click here.

Other Identifiers

A3921003

Identifier Type: -

Identifier Source: org_study_id