Multiple Dose Escalation Trial Of PF-04308515 In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01101932
First received: March 11, 2010
Last updated: July 21, 2011
Last verified: July 2011
  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-04308515 in healthy volunteers for 14 days as well as one oral dose of a tablet formulation administered for 1 day.


Condition Intervention Phase
Healthy
Drug: PF-04308515
Drug: Placebo
Drug: PF-04308515 Tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1, Placebo-Controlled, Multiple-Dose Escalation Trial Evaluating The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-04308515 (Part 1), And A Single Dose Pharmacokinetic Assessment Of A PF-04308515 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-04308515 as assessed by adverse event reporting, clinical laboratory results, vital signs, physical examinations and electrocardiograms (ECGs). [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Characterization of pharmacokinetic parameters of PF-04308515 after multiples doses which will include: Cmax, Tmax, AUC, CL/F, Vz/F, t1/2. Urinary excretion including AE% and CLr will be assessed at steady state. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Change from baseline will be utilized to assess PF-04308515's pharmacodynamic effect on biochemical and metabolic biomarkers after 14 days of dosing. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • For the tablet pharmacokinetics:Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, t1/2 will be calculated from the PF-04308515 plasma concentration versus time data. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Safety and tolerability of 1 oral dose of a tablet formulation of PF-04308515 as assessed by adverse event reporting, clinical laboratory results, vital signs, physical examinations and electrocardiograms (ECGs). [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Enrollment: 58
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: (Part 1) PF-04308515 Drug: PF-04308515
PF-04308515 will be provided as an oral solution administered at doses of 3, 10, 30 and 100 mg. If an optional cohort is needed the dose would not exceed the established toxicokinetic exposure limits. Solution will be administered orally once daily for 14 days.
Placebo Comparator: (Part 1) Solution Placebo Drug: Placebo
Placebo solution will be administered to those volunteers who are randomized to the placebo arm. Placebo solution will be administered orally once daily for 14 days.
Experimental: (Part 2) PF-04308515 Tablet Drug: PF-04308515 Tablet
Tablet formulation to administer a 20 mg dose will be administered to volunteers in Part 2. The study medication will be administered orally once daily for 1 day.

  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
  • Females are required to be surgically sterile

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
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: NCT01101932

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
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: NCT01101932     History of Changes
Other Study ID Numbers: B0861002
Study First Received: March 11, 2010
Last Updated: July 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Safety
Tolerability
Pharmacokinetics/Pharmacodynamics
Rheumatoid Arthritis
healthy volunteers

ClinicalTrials.gov processed this record on July 24, 2014