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Completed

NCT Number: NCT00902460

CP-690,550 and Midazolam Drug-Drug Interaction Study

CP-690,550 and midazolam are metabolized by similar enzymes in the liver. This study is designed to assess whether co-administration of CP-690,500 and midazolam will effect the metabolism of midazolam in healthy volunteers.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and/or female (non-child bearing potential) subjects

Exclusion criteria

  • Clinically significant infections within the past 3 months
  • History of previously untreated infection with Mycobacterium tuberculosis
  • Positive screening test for hepatitis B surface antigen, anti-hepatitis C antibody, or human immunodeficiency virus

Treatment and study plan

midazolam; CP-690,550 + midazolam

Drug

Period 1 : 2 mg midazolam oral syrup alone Period 2: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID

CP-690,550 + midazolam; midazolam

Drug

Period 1: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID Period 2: 2 mg midazolam oral syrup alone

Primary outcomes

  1. AUCinf of midazolam

    Time frame: 10 Days

Secondary outcomes

  1. AUClast, Cmax, Tmax, t1/2 of midazolam

    Time frame: 10 Days

  2. Vital signs, laboratory tests and adverse events

    Time frame: 10 Days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, 2-Way Crossover, Multiple Dose, Open Label Study Of The Effect Of CP-690,550 On Midazolam Pharmacokinetics In Healthy Volunteers

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 15, 2009
Registry last updated
Aug 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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