A Multiple Dose Study To Determine Safety, Tolerability, and Pharmacokinetics Of PF-04634817 In Healthy Adult Subjects

NCT01140672 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2011-06-08

No results posted yet for this study

Summary

The goals of this study are to evaluate the safety and tolerability of multiple ascending doses of PF-04634817 administered orally to healthy adult subjects. In additional, the plasma and urinary pharmacokinetics of multiple ascending doses of PF-04634817 administered orally to healthy adult subjects will be evaluated. Finally, the effect of multiple doses of PF-04634817 on circulating monocytes will be explored.

Conditions

  • Healthy

Interventions

DRUG

PF-04634817

Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.

DRUG

PF-04634817

Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.

DRUG

PF-04634817

Oral solution of PF-04634817 at 30 mg will be given once daily for 14 days.

DRUG

PF-04634817

Oral solution of PF-04634817 at 100 mg will be given once daily for 14 days.

DRUG

PF-04634817

Oral solution of PF-04634817 at 300 mg will be given once daily for 14 days.

DRUG

PF-04634817

Cohort will only be dosed if necessary. Dose selected for this cohort may be a repeat of a previous cohort or intermediate dose not to exceed 300 mg.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01140672 on ClinicalTrials.gov