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Effect Of Ketoconazole On The Pharmacokinetics Of Tasocitinib (CP-690,550) In Healthy Volunteers

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 13, 2010
Last updated: February 15, 2011
Last verified: February 2011
Estimate the effect of oral ketoconazole administration (400 mg once daily over 3 days) on the pharmacokinetics (process by which the drug is absorbed, distributed, metabolized, and eliminated by the body) of single 10 mg dose of tasocitinib (CP-690,550) in normal healthy volunteers.

Condition Intervention Phase
Healthy Drug: Tasocitinib (CP-690,55) plus Ketoconazole Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Open Label, Fixed-Sequence Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Tasocitinib (CP-690,550) In Healthy Volunteers

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUCinf of tasocitinib (CP-690,550) [ Time Frame: 5 days ]

Secondary Outcome Measures:
  • AUClast, Cmax, and Tmax of tasocitinib (CP-690,550) [ Time Frame: 5 days ]
  • Safety: laboratory tests, AE reporting and vital signs [ Time Frame: 5 days ]

Enrollment: 12
Study Start Date: September 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tasocitinib (CP-690,550) plus Ketoconazole Drug: Tasocitinib (CP-690,55) plus Ketoconazole
Period 1, Day 1: tasocitinib (CP-690,550) as a single oral 10 mg dose given as two 5 mg tablets Period 2, Days 1-2: ketoconazole as a daily single oral 400 mg (dose given as two 200 mg tablets Period 2, Day 3: ketoconazole as a single oral 400 mg dose given as two 200 mg tablets PLUS tasocitinib (CP-690,550) as a single oral 10 mg oral dose given as two 5 mg tablets Period 2, Day 4: No treatment (discharge)


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years

Exclusion Criteria:

  • Clinically significant disease
  • Recent history of serious infection
  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 identifier: NCT01202240

Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01202240     History of Changes
Other Study ID Numbers: A3921054
Study First Received: September 13, 2010
Last Updated: February 15, 2011

Keywords provided by Pfizer:
Drug-Drug Interaction
Healthy Volunteers
Tasocitinib (CP-690

Additional relevant MeSH terms:
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Protein Kinase Inhibitors processed this record on August 18, 2017