Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Low Dose PF-03635659 · 1 trial · 5 indications
FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Trough FEV1 was calculated as the average of the largest FEV1 value from 3 readings recorded at 24 hours (hrs) and 24.5 hrs post-dose. Baseline FEV1 value was calculated as average of 2 largest pre-dose readings on Day 1 for each period. Change from baseline in trough FEV1 was the difference between trough FEV1 and baseline FEV1.
Cmax was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞).
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞). AUC (0-∞) was dose normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| active comparator | ACTIVE_COMPARATOR | - |
| PF-03635659 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| placebo | DRUG | oral inhaled formulation, single dose |
| active comparator | DRUG | oral inhaled formulation, single dose |
| Low Dose PF-03635659 | DRUG | oral inhaled formulation, single dose, low dose |
| Mid Dose PF-03635659 | DRUG | oral inhaled formulation, single dose, mid dose |
| High Dose PF-03635659 | DRUG | oral inhaled formulation, single dose, high dose |
Inclusion Criteria: * Male or female (women of non-childbearing potential) subjects between the ages of 40 and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who meet the following criteria for GOLD stage II disease * Body Mass Index (BMI) of less than 35.5 kg/m2; and...
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.
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.
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.
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.
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.