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A Single Dose Escalation Study In Healthy Volunteers To Determine The Pharmacokinetics, Safety And Tolerability Of PF-05089771 In Healthy Volunteers

NCT01259882 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2012-02-02

No results posted yet for this study

Summary

This is a two part study. The purpose of the first part is primarily to determine the safety and toleration and pharmacokinetics of PF-05089771 following single escalating doses. Secondary objectives will be to investigate the PK of an alternative formulation of PF-05089771 and the effect of food on the PK of PF-05089771. The second part of the study will focus on investigation of the exploratory pharmacodynamics of PF-05089771 using novel biomarkers in healthy volunteers. The doses selected in Part B will have been administered previously in Part A of the study.

Conditions

Interventions

DRUG

PF-05089771

Subjects will receive single ascending doses of PF-05089771 or placebo to investigate the safety/tolerability and PK of PF-05089771. The PK of alternative formulations of PF-05089771 and the effect of food on PK may also be investigated.

DRUG

PF-05089771

Subjects will receive single ascending doses of PF-05089771 or placebo to investigate the safety/tolerability and PK of PF-05089771. The PK of alternative formulations of PF-05089771 and the effect of food on PK may also be investigated.

DRUG

PF-05089771

Subjects will receive single doses of PF-05089771 or placebo in a fully randomized crossover design. The investigation of the safety/tolerability and PK of PF-05089771 will occur. In addition the exploratory pharmacodynamics of PF-05089771 will be investigated using novel biomarkers.

DRUG

PF-05089771

Subjects will receive single doses of PF-05089771 or placebo in a fully randomized crossover design. The investigation of the safety/tolerability and PK of PF-05089771 will occur.

DRUG

PF-05089771

Subjects will receive single doses of PF-05089771 or placebo in a fully randomized crossover design. The investigation of the safety/tolerability and PK of PF-05089771 will occur.

DRUG

PF-05089771

Subjects will receive single doses of PF-05089771 or placebo in a fully randomized crossover design. The investigation of the safety/tolerability and PK of PF-05089771 will occur.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Belgium

Study Locations

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Entities

Diseases
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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 NCT01259882 on ClinicalTrials.gov