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

• ClinicalTrials.gov Identifier: NCT01204112
• Recruitment Status: Completed
• First Posted: September 17, 2010
• Last Update Posted: October 22, 2010
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: September 15, 2010
• First Posted Date: September 17, 2010
• Last Update Posted Date: October 22, 2010
• Study Start Date: September 2010
• Actual Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 15, 2010)

• AUCinf of tasocitinib (CP-690,550) [ Time Frame: 9 days ]
• Cmax of tasocitinib (CP-690,550) [ Time Frame: 9 days ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 15, 2010)

• AUClast, Tmax, t1/2 of tasocitinib (CP-690,550) [ Time Frame: 9 days ]
• Safety: clinical laboratory abnormalities, AE reporting, and vital signs (blood pressure/pulse rate). [ Time Frame: 9 days ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Estimate The Effect Of Repeat-Dose Rifampin On The Pharmacokinetics Of CP-690,550 In Healthy Volunteers
• 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
• Brief Summary: 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

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)

Study Arms

Experimental: Tasocitinib (CP-690,550) plus Rifampin

Intervention: Drug: Tasocitinib (CP-690,550) plus Rifampin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 15, 2010): 12
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 2010
• Actual Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy male and/or female subjects (of non-childbearing potential)

Exclusion Criteria:

• Clinically significant disease or condition
• Recent serious infection

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01204112
• Other Study ID Numbers: A3921056
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: October 2010