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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00902460
First received: May 14, 2009
Last updated: August 12, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: midazolam; CP-690,550 + midazolam
Drug: CP-690,550 + midazolam; midazolam
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUCinf of midazolam [ Time Frame: 10 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUClast, Cmax, Tmax, t1/2 of midazolam [ Time Frame: 10 Days ] [ Designated as safety issue: Yes ]
  • Vital signs, laboratory tests and adverse events [ Time Frame: 10 Days ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: June 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Sequence 1 Drug: midazolam; CP-690,550 + midazolam
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
Experimental: Treatment Sequence 2 Drug: CP-690,550 + midazolam; midazolam
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902460

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00902460     History of Changes
Other Study ID Numbers: A3921059
Study First Received: May 14, 2009
Last Updated: August 12, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
drug interactions CYP3A4 CYP3A5 midazolam anti-rheumatic agents

Additional relevant MeSH terms:
Midazolam
Tofacitinib
Adjuvants, Anesthesia
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014