Healthy
Conditions
Keywords
Drug-Drug Interaction, Healthy Volunteers, Tasocitinib (CP-690, 550), Ketoconazole
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.
Interventions
DRUGTasocitinib (CP-690,55) plus Ketoconazole
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)
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCinf of tasocitinib (CP-690,550) | 5 days |
Secondary
| Measure | Time frame |
|---|---|
| AUClast, Cmax, and Tmax of tasocitinib (CP-690,550) | 5 days |
| Safety: laboratory tests, AE reporting and vital signs | 5 days |
Countries
Belgium
Outcome results
None listed