Effect Of Ketoconazole On The Pharmacokinetics Of Tasocitinib (CP-690,550) In Healthy Volunteers
NCT01202240
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Clinically significant disease
- Recent history of serious infection
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Effect Of Ketoconazole On The Pharmacokinetics Of Tasocitinib (CP-690,550) In Healthy Volunteers | |||
| Official Title ICMJE | A Phase 1, Open Label, Fixed-Sequence Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Tasocitinib (CP-690,550) In Healthy Volunteers | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science | |||
| Condition ICMJE | Healthy | |||
| Intervention ICMJE | Drug: Tasocitinib (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) | |||
| Study Arms ICMJE | Experimental: Tasocitinib (CP-690,550) plus Ketoconazole
Intervention: Drug: Tasocitinib (CP-690,55) plus Ketoconazole | |||
| Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 12 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | September 2010 | |||
| Actual Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 55 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Belgium | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01202240 | |||
| Other Study ID Numbers ICMJE | A3921054 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | February 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||