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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01204112
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Days): 30
• Patients Per Site Per Month: 12.2

Study Details

Study Description

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

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• 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 Repeat-Dose Rifampin On The Pharmacokinetics Of CP-690,550 In Healthy Volunteers
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

1. AUCinf of tasocitinib (CP-690,550) [9 days]

2. Cmax of tasocitinib (CP-690,550) [9 days]

Secondary Outcome Measures

1. AUClast, Tmax, t1/2 of tasocitinib (CP-690,550) [9 days]

2. Safety: clinical laboratory abnormalities, AE reporting, and vital signs (blood pressure/pulse rate). [9 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01204112
• Other Study ID Numbers: A3921056
• First Posted: Sep 17, 2010
• Last Update Posted: Oct 22, 2010
• Last Verified: Oct 1, 2010

• Keywords provided by , ,: Drug-Drug Interaction; Tasocitinib (CP-690; 550); Rifampin; Healthy Volunteers
• Additional relevant MeSH terms: Rifampin; Tofacitinib

Study Results

No Results Posted as of Oct 22, 2010