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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797342
• Other study ID #: B0881001
• Status: Completed
• Phase: Phase 1
• First received: November 19, 2008
• Last updated: May 1, 2009
• Start date: December 2008
• Est. completion date: April 2009

Study information

• Verified date: May 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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)
• 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)
• 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)

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics e.g., maximum concentration and area under the concentration-time curve		2 weeks	Yes
Primary	Safety/Tolerability e.g., reported adverse events and safety laboratory studies		2 weeks	Yes
Primary	Pharmacodynamics e.g., changes in a peripheral blood biomarker		2 weeks	Yes

External Links

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