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

Phase 1CompletedNCT01202240

Pfizer12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Tasocitinib (CP-690,55) plus KetoconazoleDRUG

Period 1, Day 1: tasocitinib (CP-690,550) as a single oral 10 mg dose given as two 5 mg tablets Period 2, Days 1-2: ketoconazole as a daily single oral 400 mg (dose given as two 200 mg tablets Period 2, Day 3: ketoconazole as a single oral 400 mg dose given as two 200 mg tablets PLUS tasocitinib (CP-690,550) as a single oral 10 mg oral dose given as two 5 mg tablets Period 2, Day 4: No treatment (discharge)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Brussels, Belgium

Outcomes

Primary Outcomes

AUCinf of tasocitinib (CP-690,550)

Time frame: 5 days

Secondary Outcomes

AUClast, Cmax, and Tmax of tasocitinib (CP-690,550)

Time frame: 5 days

Safety: laboratory tests, AE reporting and vital signs

Time frame: 5 days

Data from ClinicalTrials.gov

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