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PF03635659

Phase 1

Chronic Obstructive Pulmonary Disease | Small molecule | Respiratory |Pfizer, Inc.|Last Updated: Mar 23, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

PF03635659 · 1 trial · 1 indication

Phase 1 1
NCT00864786Multiple Dose Healthy Volunteer Safety Pharmacokinetics StudyChronic Obstructive Pulmonary Disease
COMPLETED50 Analytics
PHASE1COMPLETED
Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study
Chronic Obstructive Pulmonary Disease
NCT0086478650
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Study Endpoints

Primary Endpoints

Safety and toleration: Adverse events, vital signs measurements (supine and standing), 12-lead ECGs, spirometry (FEV1, FVC), laboratory safety tests, physical examination, and subject-reported dry mouth assessment.
3 Weeks
Pharmacokinetics: Plasma: Cmax, Tmax, AUCinf, AUCτ, t½, accumulation ratio, linearity ratio.
3 Weeks
Pharmacodynamics: Salivary flow rate
3 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTAL200 mcg
Cohort 2EXPERIMENTAL600 mcg
Cohort 3EXPERIMENTAL1000 mcg
Cohort 4EXPERIMENTALDose to be decided
Cohort 5EXPERIMENTALDose to be decided

Interventions

NameTypeDescription
PF03635659DRUGInhaled doses of 200 mcgQD
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects between the ages of 18 and 55 years, inclusive (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 l...

Countries:Belgium
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Frequently asked questions about PF03635659

What is Low Dose PF-03635659 used for?

Low Dose PF-03635659 is an investigational small molecule being developed for Chronic Obstructive Pulmonary Disease (COPD). It is intended to treat respiratory conditions including Pulmonary Disease, Chronic Obstructive, Lung Diseases, and Chronic Obstructive Airway Disease. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Low Dose PF-03635659?

Low Dose PF-03635659 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of Chronic Obstructive Pulmonary Disease.

What phase is Low Dose PF-03635659 in?

Low Dose PF-03635659 is in Phase 2 clinical development. It has completed one Phase 2 trial and one Phase 1 trial. The drug remains investigational and has not received FDA approval. It is being studied for its safety, pharmacokinetics, and pharmacodynamics in patients with Chronic Obstructive Pulmonary Disease.

What clinical trials is Low Dose PF-03635659 in?

Low Dose PF-03635659 has been studied in two completed clinical trials. NCT00864786 was a Phase 1 healthy volunteer study in Belgium examining safety and pharmacokinetics. NCT01033487 was a Phase 2 study in Germany evaluating safety, pharmacokinetics, and pharmacodynamics in patients with Chronic Obstructive Pulmonary Disease.

Is Low Dose PF-03635659 the same as PF-03635659?

Yes, Low Dose PF-03635659 is the same drug as PF-03635659. The term "Low Dose" refers to a specific dosage strength being studied. Clinical trials such as NCT01033487 use the name PF-03635659 to describe the investigational drug being evaluated for Chronic Obstructive Pulmonary Disease.