A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT00812825|
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : August 12, 2009
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: PF-04171327 Drug: Prednisolone Drug: Placebo Drug: Placebo Solution Drug: PF-04171327 Tablet||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||A Phase 1, Active and Placebo-Controlled, Multiple-Dose Escalation Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04171327 (Part 1), and a Single Dose Pharmacokinetic Assessment of a Tablet Formulation (Part 2) in Healthy Volunteers|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
PF-0417327 will be provided as an oral solution administered at doses of 1, 3, 10 and 30 mg. If an additional cohort is required, the dose selected will not exceed 100 mg. Solution will be administered once daily for 14 days.
|Active Comparator: Prednisolone||
Oral doses of prednisolone (5, 10, and 20 mg) will be administered to the first three cohorts. The fourth cohort will receive between 1 and 20 mg to be determined after the third cohort completes dosing. If an additional cohort is required, the dose selected will not exceed 40 mg. Prednisolone tablets will be administered once daily for 14 days
|Placebo Comparator: Placebo||
Tablets similar in appearance to prednisolone will be administered once daily for 14 days.
|Sham Comparator: Solution Placebo||
Drug: Placebo Solution
Placebo solution will be administered to those volunteers who are randomized to the placebo or prednisolone arms. This will be administered orally each day for 14 days.
|Experimental: PF-04171327 Tablet||
Drug: PF-04171327 Tablet
A single 10 mg dose of PF-04171327 tablet formulation will be administered orally to volunteers in Part 2 of this study.
- Safety and tolerability of multiple doses of PF-04171327 [ Time Frame: 14 days ]
- Determination of pharmacokinetic parameters of PF-04171327 after multiple doses [ Time Frame: 14 days ]
- Assessment of the pharmacodynamic effects of PF-04171327 on chemical and metabolic biomarkers [ Time Frame: 14 days ]
- Evaluation of the pharmacokinetic parameters of a single 10 mg dose of PF-04171327 tablet [ Time Frame: 1 day ]
- To characterize the pharmacodynamic effects of prednisolone [ Time Frame: 14 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812825
|Pfizer Investigational Site|
|Bruxelles, Belgium, 1070|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|