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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Tasocitinib (CP-690,55) plus Ketoconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01202240

A3921054

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Tasocitinib (CP-690,550) plus Ketoconazole

Experimental group

Treatment:

Drug: Tasocitinib (CP-690,55) plus Ketoconazole