A Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of PF-03654764 In Combination With Fexofenadine In Healthy Subjects

A Phase 1 Double-blind (3rd Party Open), Randomized, Placebo-controlled Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of Pf-03654764 In Combination With Fexofenadine In Healthy Subjects

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01298505

Enrollment

Registered

2011-02-17

Start date

2010-06-04

Completion date

2010-06-04

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Phase 1 multiple dose safety toleration fexofenadine

Brief summary

The purpose of this study in heathy people is to investigate the safety, toleration and time course of PF-03654764 in the blood, following multiple doses given by mouth together with fexofenadine.

Interventions

DRUGPF-03654764 2.5mg plus fexofenadine 60mg

PF-03654764 2.5mg plus fexofenadine 60mg twice daily for 7 days

DRUGPF-03654764 5mg plus fexofenadine 60mg

PF-03654764 5mg plus fexofenadine 60mg twice daily for 7 days

DRUGplacebo

placebo given twice daily for 7 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

Exclusion criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * A positive urine drug screen. * Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse events as a measure of safety and tolerability.	30 days

Secondary

Measure	Time frame
Plasma concentrations of PF-03654764 will be measured.	7 days

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026