A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04629991 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00797342
First received: November 19, 2008
Last updated: May 1, 2009
Last verified: May 2009
  Purpose

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04629991 in healthy subjects. Dose exploration will proceed in a step-wise manner, beginning with low doses not expected to have significant biological effects and proceeding to doses approximating or exceeding the anticipated therapeutic level. Doses to be explored may be limited by tolerability, and will not exceed levels previously shown to be tolerable in animals.


Condition Intervention Phase
Healthy Volunteers
Drug: PF-04629991
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Phase 1, Randomized, Double Blind (Sponsor Open), Placebo Controlled, Single-Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effect of PF-04629991 in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pharmacokinetics e.g., maximum concentration and area under the concentration-time curve [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Safety/Tolerability e.g., reported adverse events and safety laboratory studies [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacodynamics e.g., changes in a peripheral blood biomarker [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: December 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
first of three dosing cohorts Drug: PF-04629991
Oral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the first cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses)
second of three dosing cohorts Drug: PF-04629991
Oral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the second cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses)
third of three dosing cohorts Drug: PF-04629991
Oral; sequential single dose escalation; three fourteen-day treatment periods per subject in the third cohort; randomized assignment to treatment (placebo or PF-04629991)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy non-smoking men and women
  • body mass index 18-30 kg/m2

Exclusion Criteria:

  • Women must not be able to have children
  • no current infections
  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: NCT00797342

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: NCT00797342     History of Changes
Other Study ID Numbers: B0881001
Study First Received: November 19, 2008
Last Updated: May 1, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Pfizer:
rheumatoid arthritis First in human safety pharmacokinetics pharmacodynamics

ClinicalTrials.gov processed this record on August 28, 2014