|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01204112 |
|
Date of registration:
|
15/09/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Estimate The Effect Of Repeat-Dose Rifampin On The Pharmacokinetics Of CP-690,550 In Healthy Volunteers
|
|
Scientific title:
|
A Phase 1, Open Label, Fixed-Sequence Study To Estimate The Effect Of Repeat-Dose Rifampin On The Pharmacokinetics Of CP-690,550 In Healthy Volunteers |
|
Date of first enrolment:
|
September 2010 |
|
Target sample size:
|
12 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01204112 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Pfizer CT.gov Call Center |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Pfizer |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Healthy male and/or female subjects (of non-childbearing potential)
Exclusion Criteria:
- Clinically significant disease or condition
- Recent serious infection
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Healthy
|
|
Intervention(s)
|
|
Drug: Tasocitinib (CP-690,550) plus Rifampin
|
|
Primary Outcome(s)
|
|
AUCinf of tasocitinib (CP-690,550)
[Time Frame: 9 days]
|
|
Cmax of tasocitinib (CP-690,550)
[Time Frame: 9 days]
|
|
Secondary Outcome(s)
|
|
AUClast, Tmax, t1/2 of tasocitinib (CP-690,550)
[Time Frame: 9 days]
|
|
Safety: clinical laboratory abnormalities, AE reporting, and vital signs (blood pressure/pulse rate).
[Time Frame: 9 days]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|