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PF-00610355

Phase 2

Pulmonary Disease, Chronic Obstructive | Small molecule | Respiratory |Pfizer, Inc.|Last Updated: Feb 6, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment425

FDA Designations

No designations recorded

Clinical trial landscape

PF-00610355 · 3 trials · 6 indications

Phase 2 2Phase 1 1
NCT00808288A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.Pulmonary Disease, Chronic Obstructive
COMPLETED405 Analytics
NCT00783406Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.Pulmonary Disease, Chronic Obstructive
COMPLETED20 Analytics
PHASE2COMPLETED
A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.
Pulmonary Disease, Chronic ObstructiveUnlock trial analytics
PHASE2COMPLETED
Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.
Pulmonary Disease, Chronic ObstructiveUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in trough FEV1
6 week
To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients.
up to 8 days post dose
To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients
up to 24 hours post dose
To assess whether multiple dose administration of PF00610335 has the potential to affect QTc in healthy volunteers
24 hours

Secondary Endpoints

Maximal and mean changes from baseline in heart rate, QTc and plasma potassium
each visit
Change from baseline in peak FEV1
0-6 hours /6 weeks
Change from baseline in trough and peak FEV6, FVC and IC
6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PF-00610355EXPERIMENTAL -
PF- 00610355EXPERIMENTAL -
PF - 00610355EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
SalmeterolACTIVE_COMPARATOR -
PF -00610355EXPERIMENTAL -
PF-00610355 450 µgEXPERIMENTALAn orally inhaled dose of PF-00610355 450 µg
PF-00610355 1200 µgEXPERIMENTALAn orally inhaled dose of PF-00610355 1200 µg
moxifloxacin 400 mgACTIVE_COMPARATORA single oral dose of moxifloxacin 400 mg on Day 4.

Interventions

NameTypeDescription
PF-00610355DRUGoral, inhaled, dry powder, 600ug, OD
PF - 00610355DRUGoral, inhaled, dry powder, 300ug, OD
PF- 00610355DRUGoral, inhaled, dry powder, 100ug, OD
PlaceboDRUGoral, inhaled, dry powder, placebo, OD
SalmeterolDRUGsalmeterol, 50ug, BID
moxifloxacinDRUGA single oral dose of moxifloxacin 400 mg on Day 4.
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Eligibility Criteria

Age Range40 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites75

Inclusion Criteria: * Post-bronchodilator FEV1/FVC ratio \<0.7 and a post-bronchodilator FEV1 of 50-80%. * Diagnosis of moderate COPD for a minimum of 6 months. * Stable disease for at least 1 month prior to screening Exclusion Criteria: * More than 2 exacerbations of COPD requiring treatment wit...

Countries:United StatesArgentinaBulgariaCroatiaCzechiaGermanyHungaryPolandSlovakiaSouth AfricaSpainTurkey (Türkiye)Belgium
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Frequently asked questions about PF-00610355

What is PF-00610355 used for?

PF-00610355 is an investigational small molecule being developed for the treatment of chronic obstructive pulmonary disease (COPD). It has been studied in clinical trials involving COPD patients to evaluate its safety, toleration, and efficacy. The drug is administered via inhalation and is currently in clinical development, though it is not yet approved.

Who makes PF-00610355?

PF-00610355 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer has conducted multiple clinical trials to investigate the drug's safety and efficacy in patients with chronic obstructive pulmonary disease.

What phase is PF-00610355 in?

PF-00610355 is in Phase 1 clinical development. While some completed trials were designated as Phase 2, the overall development stage is Phase 1. The drug is investigational and has not been approved by regulatory authorities. All clinical trials for PF-00610355 have been completed, with no active trials currently ongoing.

What clinical trials is PF-00610355 in?

PF-00610355 has been studied in three completed clinical trials. NCT00783406 and NCT00808288 evaluated the drug in COPD patients, while NCT01107054 investigated its effects on the QT/QTc interval in healthy volunteers. These trials were conducted in multiple countries, including the United States, Germany, and Belgium.

Is PF-00610355 the same as PF00610335?

No, PF-00610355 and PF00610335 are different compounds. A clinical trial (NCT01107054) investigated the effects of PF00610335 on the QT/QTc interval in healthy volunteers, but this is a separate drug from PF-00610355, which is being studied for chronic obstructive pulmonary disease.