Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis

Conditions

• Immunomodulation
• Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• tofacitinib — DRUG
  5 mg BID For 13 days and once on Day 14
• tofacitinib — DRUG
  10 mg BID for 13 days and once on Day 14\*
• tofacitinib — DRUG
  20 mg BID for 13 days and once on Day 14
• tofacitinib — DRUG
  30 mg BID for 13 days and once on Day 14
• tofacitinib — DRUG
  60 mg tablet once a day (QD) for 14 days
• tofacitinib — DRUG
  50 mg tablets two times a day (BID) for 13 days and once on day 14

Study Details

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.

Key Dates

Start date

Nov 30, 2002

Status verified

Jan 2013

Primary completion

Apr 30, 2004

Completion

Apr 30, 2004

Study Design

Enrollment

59 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 5 mg BID
  5 mg BID for 13 days and once on Day 14
• Experimental: 10 mg BID
  10 mg BID for13 days and once on Day 14\*
• Experimental: 20 mg BID
  20 mg BID for 13 days and once on Day 14
• Experimental: 30 mg BID
  30 mg BID for 13 days and once on Day 14
• Experimental: 60 mg QD
  60 mg QD for 14 days
• Experimental: 50 mg BID
  50 mg BID x 13 days and once on day 14

Primary Outcome Measure

Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1 [ Time Frame: 23 hours (hrs) prior to morning dose on Day 1 (Baseline for HPD 1), 1 hour (hr) post morning dose on Day 1 ]

Locations (1)

Find similar trials in Little Rock, AR

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