MedDataX Logo

Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults

NCT ID: NCT00793000

Last Updated: 2011-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of PF-04287881 after a single oral dose in healthy adult volunteers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Safety, Tolerability and Efficacy of XC221 in Patients With Uncomplicated Influenza or Other Acute Viral Upper Respiratory Infections

NCT05030324

Influenza Viral Respiratory Infection Acute Viral Upper Respiratory Infections
COMPLETED PHASE2

A Study to Understand the Effect and Safety of the Study Medicine PF-07817883 in Adults Who Have Symptoms of COVID-19 But Are Not Hospitalized

NCT05799495

SARS-CoV-2 Infection
COMPLETED PHASE2

Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections

NCT03455491

Acute Respiratory Viral Infections Influenza
COMPLETED PHASE2

Study to Assess Safety, Tolerability and Pharmacokinetics of XC221 in Healthy Volunteers

NCT03459391

Influenza Acute Respiratory Infection
COMPLETED PHASE1

First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending And Multiple Ascending Doses of PF-07304814 In Hospitalized Participants With COVID-19.

NCT04535167

Viral Disease
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Tract Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

Group Type EXPERIMENTAL

PF-04287881

Intervention Type DRUG

75 mg oral dose (prepared solution) given once

Placebo

Intervention Type DRUG

placebo to match 75 mg oral dose (prepared solution), given once

Cohort 2

Group Type EXPERIMENTAL

PF-04287881

Intervention Type DRUG

150 mg oral dose (prepared solution) given once

Placebo

Intervention Type DRUG

placebo to match 150 mg oral dose (prepared solution), given once

Cohort 3

Group Type EXPERIMENTAL

PF-04287881

Intervention Type DRUG

300 mg oral dose (prepared solution) given once

Placebo

Intervention Type DRUG

placebo to match 300 mg oral dose (prepared solution), given once

Cohort 4

Group Type EXPERIMENTAL

PF-04287881

Intervention Type DRUG

750 mg oral dose (prepared solution) given once

Placebo

Intervention Type DRUG

placebo to match 750 mg oral dose (prepared solution), given once

Cohort 5

Group Type EXPERIMENTAL

PF-04287881

Intervention Type DRUG

1000 mg oral dose (prepared solution) given once

Placebo

Intervention Type DRUG

placebo to match 1000 mg oral dose (prepared solution), given once

Cohort 6

Group Type EXPERIMENTAL

PF-04287881

Intervention Type DRUG

1250 mg oral dose (prepared solution) given once

Placebo

Intervention Type DRUG

placebo to match 1250 mg oral dose (prepared solution), given once

Cohort 7

Group Type EXPERIMENTAL

PF-04287881

Intervention Type DRUG

1500 mg oral dose (prepared solution) given once

Placebo

Intervention Type DRUG

placebo to match 1500 mg oral dose (prepared solution), given once

Cohort 8

Japanese volunteers, low dose previously tested (based on PK)

Group Type EXPERIMENTAL

PF-04287881

Intervention Type DRUG

300 mg oral dose (prepared solution) given once

Placebo

Intervention Type DRUG

placebo to match 300 mg oral dose (prepared solution), given once

Cohort 9

Japanese volunteers, intermediate dose previously tested (based on PK)

Group Type EXPERIMENTAL

PF-04287881

Intervention Type DRUG

750 mg oral dose (prepared solution) given once

Placebo

Intervention Type DRUG

placebo to match 750 mg oral dose (prepared solution), given once

Cohort 10

Japanese volunteers, high dose previously tested (based on safety)

Group Type EXPERIMENTAL

PF-04287881

Intervention Type DRUG

1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once

Placebo

Intervention Type DRUG

placebo to match 1000 mg oral dose (prepared solution), given once

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-04287881

75 mg oral dose (prepared solution) given once

Intervention Type DRUG

Placebo

placebo to match 75 mg oral dose (prepared solution), given once

Intervention Type DRUG

PF-04287881

150 mg oral dose (prepared solution) given once

Intervention Type DRUG

Placebo

placebo to match 150 mg oral dose (prepared solution), given once

Intervention Type DRUG

PF-04287881

300 mg oral dose (prepared solution) given once

Intervention Type DRUG

Placebo

placebo to match 300 mg oral dose (prepared solution), given once

Intervention Type DRUG

PF-04287881

750 mg oral dose (prepared solution) given once

Intervention Type DRUG

Placebo

placebo to match 750 mg oral dose (prepared solution), given once

Intervention Type DRUG

PF-04287881

1000 mg oral dose (prepared solution) given once

Intervention Type DRUG

Placebo

placebo to match 1000 mg oral dose (prepared solution), given once

Intervention Type DRUG

PF-04287881

1250 mg oral dose (prepared solution) given once

Intervention Type DRUG

Placebo

placebo to match 1250 mg oral dose (prepared solution), given once

Intervention Type DRUG

PF-04287881

1500 mg oral dose (prepared solution) given once

Intervention Type DRUG

Placebo

placebo to match 1500 mg oral dose (prepared solution), given once

Intervention Type DRUG

PF-04287881

300 mg oral dose (prepared solution) given once

Intervention Type DRUG

Placebo

placebo to match 300 mg oral dose (prepared solution), given once

Intervention Type DRUG

PF-04287881

750 mg oral dose (prepared solution) given once

Intervention Type DRUG

Placebo

placebo to match 750 mg oral dose (prepared solution), given once

Intervention Type DRUG

PF-04287881

1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once

Intervention Type DRUG

Placebo

placebo to match 1000 mg oral dose (prepared solution), given once

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule.
* Women of non-childbearing potential only.
* Japanese subjects muct have 4 Japanese grandparents who were born in Japan.

Exclusion Criteria

* Previous antibiotic use within 14 days prior to dosing.
* Use of antibiotics during hospitalization within 90 days prior to dosing.
* History of sensitivity to macrolides or ketolides.
* Presence of clinically significant eye conditions (other than corrective lenses).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pfizer, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0581001&StudyName=Safety%20And%20Pharmacokinetics%20Study%20Of%20PF-04287881%20In%20Healthy%20Adults

To obtain contact information for a study center near you, click here.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B0581001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study to Evaluate the Safety and Efficacy of XC221 in Patients With Uncomplicated Influenza or Other Acute Viral Upper Respiratory Infections
NCT05544916 COMPLETED PHASE3
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms
NCT03629184 COMPLETED PHASE3
Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults
NCT01314911 COMPLETED NA
Study to Assess Efficacy and Safety of XC221 200 mg in the Treatment of Influenza or Other ARVI
NCT03830905 COMPLETED PHASE2
A Study of EDP-235 in Healthy Subjects
NCT05246878 COMPLETED PHASE1
A Study of PC786 to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of Multiple Doses in an RSV Challenge Study
NCT03382431 COMPLETED PHASE1/PHASE2
A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza
NCT00705406 COMPLETED PHASE2
A Study of AL-794 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses, and the Antiviral Activity of Multiple Doses in an Influenza Challenge Study
NCT02588521 COMPLETED PHASE1
The Clinical Trial to Evaluate the Efficacy and Safety of CKD-497
NCT03726853 COMPLETED PHASE2
A Study to Evaluate the Efficacy and Safety of Intravenous Peramivir in Subjects With Uncomplicated Influenza.
NCT01224795 TERMINATED PHASE3
Efficacy and Safety of Molnupiravir in Healthy Participants Inoculated With Experimental Influenza Virus (MK-4482-019)
NCT05818124 COMPLETED PHASE1
A Study to Learn About The Study Medicine (Called PF-06823859) in Healthy Chinese Participants
NCT05257798 COMPLETED PHASE1
Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
NCT01227421 COMPLETED PHASE2/PHASE3
XC8 in the Treatment of Patients With Acute Respiratory Viral Infection
NCT03441373 COMPLETED PHASE2/PHASE3
Study of Acute Uncomplicated Seasonal Influenza A in Adult Subjects
NCT02342249 COMPLETED PHASE2
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Escalating Doses of GSK1325756 Solution for Infusion, and Absolute Bioavailability Relative of an Oral Dose, in Healthy Adult Subjects
NCT02169583 COMPLETED PHASE1
Single Dose and Multiple Dose Safety, Tolerability, PK，and Food Effect Study，and Interaction With Oseltamivir Study of HEC116094 in Healthy Adult Subjects
NCT04982913 COMPLETED PHASE1
First-in-Human Study of VNT-101: Safety, Tolerability, and Pharmacokinetics
NCT07169318 RECRUITING PHASE1
T-705a Multicenter Study in Adults Subjects With Uncomplicated Influenza
NCT01728753 COMPLETED PHASE1/PHASE2
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
NCT05047601 COMPLETED PHASE2/PHASE3
Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza
NCT00610935 TERMINATED PHASE3
ADC189 Tablets on Influenza A Virus Infection/Influenza B Virus Infection
NCT06342921 COMPLETED PHASE2/PHASE3
Phase 2B Study on Safety and Therapeutic Efficacy of DAS181 in Adult Subjects With Naturally Acquired Influenza
NCT01740063 COMPLETED PHASE2
Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg
NCT01271998 COMPLETED PHASE1
Safety, Tolerability, Pharmacokinetics, and Food Effect Study of RV299 in Healthy Adults
NCT06033612 COMPLETED PHASE1