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

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ClinicalTrials.gov Identifier: NCT00797342
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : May 5, 2009
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Volunteers Drug: PF-04629991 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : December 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Arm Intervention/treatment
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)




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797342


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00797342     History of Changes
Other Study ID Numbers: B0881001
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: May 5, 2009
Last Verified: May 2009

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