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

NCT00812825 | Completed Phase 1

• 1 other identifier: A9391002
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Safety Tolerability Pharmacokinetics/pharmacodynamics

Outcome Measures

Primary Outcomes (4)

• Safety and tolerability of multiple doses of PF-04171327

  14 days

• Determination of pharmacokinetic parameters of PF-04171327 after multiple doses

  14 days

• Assessment of the pharmacodynamic effects of PF-04171327 on chemical and metabolic biomarkers

  14 days

• Evaluation of the pharmacokinetic parameters of a single 10 mg dose of PF-04171327 tablet

  1 day

Secondary Outcomes (1)

• To characterize the pharmacodynamic effects of prednisolone

  14 days

Study Arms (5)

PF-04173127

EXPERIMENTAL

Drug: PF-04171327

Prednisolone

ACTIVE COMPARATOR

Drug: Prednisolone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Solution Placebo

SHAM COMPARATOR

Drug: Placebo Solution

PF-04171327 Tablet

EXPERIMENTAL

Drug: PF-04171327 Tablet

Interventions

PF-04171327 DRUG

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.

PF-04173127

Prednisolone DRUG

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

Prednisolone

Placebo DRUG

Tablets similar in appearance to prednisolone will be administered once daily for 14 days.

Placebo

Placebo Solution DRUG

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.

Solution Placebo

PF-04171327 Tablet DRUG

A single 10 mg dose of PF-04171327 tablet formulation will be administered orally to volunteers in Part 2 of this study.

PF-04171327 Tablet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males between 18 and 55 years, inclusive.
• Healthy females between 18 and 44 years, inclusive.

You may not qualify if:

• Evidence or history of clinically significant disease;
• Post-menopausal women;
• History of intolerance or significant adverse effects with glucocorticoids. therapy.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

fosdagrocorat; Prednisolone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 22, 2008
• Study Start: January 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: August 12, 2009

Record last verified: 2009-08

Locations

BE (1)