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Estimate The Effect Of Repeat-Dose Rifampin On The Pharmacokinetics Of CP-690,550 In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01204112
First received: September 15, 2010
Last updated: October 21, 2010
Last verified: October 2010
History of Changes
  Purpose

The current study is designed to estimate the effect of rifampin (600 mg orally every 24 hours for 7 days) on pharmacokinetics of single 30 mg dose (CP-690,550) in normal healthy volunteers


Condition Intervention Phase
Healthy
 Drug: Tasocitinib (CP-690,550) plus Rifampin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase 1, Open Label, Fixed-Sequence Study To Estimate The Effect Of Repeat-Dose Rifampin On The Pharmacokinetics Of CP-690,550 In Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUCinf of tasocitinib (CP-690,550) [ Time Frame: 9 days ] [ Designated as safety issue: No ]
  • Cmax of tasocitinib (CP-690,550) [ Time Frame: 9 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUClast, Tmax, t1/2 of tasocitinib (CP-690,550) [ Time Frame: 9 days ] [ Designated as safety issue: No ]
  • Safety: clinical laboratory abnormalities, AE reporting, and vital signs (blood pressure/pulse rate). [ Time Frame: 9 days ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: September 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tasocitinib (CP-690,550) plus Rifampin Drug: Tasocitinib (CP-690,550) plus Rifampin
Period 1, Day 1: Tasocitinib (CP-690,550) 30 mg (single oral dose) as six 5 mg tablets Period 2, Day 1-7: Rifampin 600 mg (single oral dose) q24h Period 2, Day 8: Tasocitinib (CP-690,550) 30 mg (single oral dose) as six 5 mg tablets Period 2, Day 9: No treatment (discharge)

  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 subjects (of non-childbearing potential)

Exclusion Criteria:

  • Clinically significant disease or condition
  • Recent serious infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204112

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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01204112     History of Changes
Other Study ID Numbers: A3921056
Study First Received: September 15, 2010
Last Updated: October 21, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Drug-Drug Interaction
Tasocitinib (CP-690
550)
Rifampin
Healthy Volunteers

Additional relevant MeSH terms:
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013