NCT01026545 is a Phase 1 clinical trial of PF-04287881 in Respiratory Tract Infections, sponsored by Pfizer.

Who is sponsoring NCT01026545?

NCT01026545 is sponsored by Pfizer.

What drugs are being tested in NCT01026545?

Interventions in NCT01026545: PF-04287881, Placebo, PF-04287881, Placebo, PF-04287881, Placebo, PF-04287881, Placebo, PF-04287881, Placebo, PF-04287881, Placebo.

What condition does NCT01026545 study?

NCT01026545 studies Respiratory Tract Infections.

Is NCT01026545 still recruiting?

NCT01026545 is currently completed. Last updated 3 May 2011.

Last reviewed 2011-05-03 · How we verify

NCT01026545

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04287881 After Administration Of Multiple Escalating Oral Doses To Healthy Adult Subjects

Completed Phase 1 Last updated 3 May 2011

What this trial tests

Phase 1 trial testing PF-04287881 in Respiratory Tract Infections in 39 participants. Completed in 1 July 2010.

Timeline

1 December 2009

Primary endpoint
1 July 2010

1 July 2010

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Enrollment	39
Start date	1 December 2009
Primary completion	1 July 2010
Estimated completion	1 July 2010
Sites	1 location across United States

Drugs / interventions tested

PF-04287881 — full drug profile →
Placebo
PF-04287881 — full drug profile →
Placebo
PF-04287881 — full drug profile →
Placebo
PF-04287881 — full drug profile →
Placebo
PF-04287881 — full drug profile →
Placebo
PF-04287881 — full drug profile →
Placebo

Conditions studied

Respiratory Tract Infections — all drugs for Respiratory Tract Infections →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 55, any sex, with Respiratory Tract Infections. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Standard safety assessments including assessment of AEs, laboratory tests, ECGs, and vital signs.
Time frame: Screening, Dosing days 1-10, through follow-up
The primary pharmacokinetic endpoints to be evaluated for PF-04287881 include Cmax, Tmax, and AUC(0-24) on Day 1 and Day 10.
Time frame: Day 1 and 10

Sponsor's own description

This study is a randomized, investigator blind, subject blind, sponsor-open, placebo controlled, multiple dose escalating, sequential, parallel cohort study of PF-04287881. Subjects will undergo screening procedures within 28 days prior to dosing. At least 1 day after the Screening visit, eligible subjects who meet the entry criteria will be admitted to the Clinical Research Unit (CRU) and confined in the unit until discharge on Day 15. Approximately 60 healthy volunteers (20 volunteers of Japanese origin for Cohorts 5 and 6), 18 to 55 years of age, males and females (women of non childbearing potential only) will be enrolled and randomized in a 4:1 ratio to treatment with either PF-04287881 or placebo within each cohort. Each cohort will have a 10 day dosing period and each will consist of 10 subjects (8 active and 2 placebo). In each cohort, each subject will receive a single daily oral dose of either placebo or PF-04287881 under fasted state for 10 days.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Respiratory Tract Infections

Currently open trials in the same condition.

NCT07207291 — Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers · Phase 1 · recruiting
NCT06715306 — Intravenous Versus Oral Treatment of the Main Acute Infections · NA · recruiting
NCT06472219 — PREDICATE Trial For Respiratory Tract Infections · Phase 3 · recruiting
NCT05914324 — Outpatient Pediatric Pulse Oximeters in Africa · NA · recruiting
NCT06579170 — Burden of Recreational Water Illness Due to Exposure to Cyanobacteria and Their Toxins in Freshwater Beaches in Canada · active not recruiting

Other Pfizer trials

Trials by the same sponsor.

NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01026545 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 3 May 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01026545.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing