A Phase 1 Multiple-Dose Escalation Study of PF-04171327 in Healthy Volunteers - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00812825

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.

Condition	Intervention	Phase
Healthy Volunteers	Drug: PF-04171327 Drug: Prednisolone Drug: Placebo Drug: Placebo Solution	Phase I

Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	A Phase 1, Active and Placebo-Controlled, Multiple-Dose Escalation Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04171327 in Healthy Volunteers

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 ]

Secondary Outcome Measures:

To characterize the pharmacodynamic effects of prednisolone [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	January 2009
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PF-04173127: Experimental	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.
Prednisolone: Active Comparator	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: Placebo Comparator	Drug: Placebo Tablets similar in appearance to prednisolone will be administered once daily for 14 days.
Solution Placebo: Sham Comparator	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.

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 glucocorticoid therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812825

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A9391002
Study First Received:	December 19, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00812825
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Pfizer:

Rheumatoid Arthritis;Safety;Tolerability; Pharmacokinetics/pharmacodynamics

Study placed in the following topic categories:

Methylprednisolone
Arthritis
Prednisolone
Arthritis, Rheumatoid

Methylprednisolone acetate
Prednisolone acetate
Healthy
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Protective Agents

Neuroprotective Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 13, 2009