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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Tasocitinib (CP-690,55) plus Ketoconazole

• Registration Number: NCT01202240
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2010-09-13
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-15
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-15
• Last Update Posted: 2011-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tasocitinib (CP-690,550) plus Ketoconazole	Tasocitinib (CP-690,55) plus Ketoconazole	-

Primary Outcome Measures

Name	Time	Method
AUCinf of tasocitinib (CP-690,550)	5 days

Secondary Outcome Measures

Name	Time	Method
AUClast, Cmax, and Tmax of tasocitinib (CP-690,550)	5 days
Safety: laboratory tests, AE reporting and vital signs	5 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium