A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00812825
First received: December 19, 2008
Last updated: August 11, 2009
Last verified: August 2009
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Purpose
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04171327 in healthy volunteers for 14 days (Part 1). Part 2 will evaluate the pharmacokinetics of a single 10 mg dose of the PF-04171327 tablet in healthy volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: PF-04171327 Drug: Prednisolone Drug: Placebo Drug: Placebo Solution Drug: PF-04171327 Tablet |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Safety and tolerability of multiple doses of PF-04171327 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
- Determination of pharmacokinetic parameters of PF-04171327 after multiple doses [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Assessment of the pharmacodynamic effects of PF-04171327 on chemical and metabolic biomarkers [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Evaluation of the pharmacokinetic parameters of a single 10 mg dose of PF-04171327 tablet [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To characterize the pharmacodynamic effects of prednisolone [ Time Frame: 14 days ] [ Designated as safety issue: No ]
| Enrollment: | 78 |
| Study Start Date: | January 2009 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PF-04173127 |
Drug: PF-04171327
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 |
Drug: 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 |
Drug: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy males between 18 and 55 years, inclusive.
- Healthy females between 18 and 44 years, inclusive.
Exclusion Criteria:
- Evidence or history of clinically significant disease;
- Post-menopausal women;
- History of intolerance or significant adverse effects with glucocorticoids. therapy.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00812825 History of Changes |
| Other Study ID Numbers: | A9391002 |
| Study First Received: | December 19, 2008 |
| Last Updated: | August 11, 2009 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by Pfizer:
|
Safety Tolerability Pharmacokinetics/pharmacodynamics |
Additional relevant MeSH terms:
|
Methylprednisolone acetate Prednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on June 18, 2013