NCT01202240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2010

Completed
Last Updated

February 17, 2011

Status Verified

February 1, 2011

Enrollment Period

Same day

First QC Date

September 13, 2010

Last Update Submit

February 15, 2011

Conditions

Healthy

Keywords

Drug-Drug InteractionHealthy VolunteersTasocitinib (CP-690550)Ketoconazole

Outcome Measures

Primary Outcomes (1)

  • AUCinf of tasocitinib (CP-690,550)

    5 days

Secondary Outcomes (2)

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

    5 days

  • Safety: laboratory tests, AE reporting and vital signs

    5 days

Study Arms (1)

Tasocitinib (CP-690,550) plus Ketoconazole

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

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)

Tasocitinib (CP-690,550) plus Ketoconazole

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years

You may not qualify if:

  • Clinically significant disease
  • Recent history of serious infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Publications (1)

  • Gupta P, Chow V, Wang R, Kaplan I, Chan G, Alvey C, Ni G, Ndongo MN, LaBadie RR, Krishnaswami S. Evaluation of the effect of fluconazole and ketoconazole on the pharmacokinetics of tofacitinib in healthy adult subjects. Clin Pharmacol Drug Dev. 2014 Jan;3(1):72-7. doi: 10.1002/cpdd.71. Epub 2013 Oct 8.

    PMID: 27128233DERIVED

Related Links

MeSH Terms

Interventions

tofacitinib

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 15, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

February 17, 2011

Record last verified: 2011-02

Locations

BE(1)