A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00812825
First received: December 19, 2008
Last updated: August 11, 2009
Last verified: August 2009
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  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
Pharmaceutical Solutions
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 August 21, 2014