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
  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:


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
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: 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:
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
Tofacitinib
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
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014