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

NCT00797342 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2009-05-05

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

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)

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)

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)

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00797342 on ClinicalTrials.gov