Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Low Dose PF-03635659
PF03635659 · 2 trials · 6 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 | - |
| Cohort 1 | EXPERIMENTAL | 200 mcg |
| Cohort 2 | EXPERIMENTAL | 600 mcg |
| Cohort 3 | EXPERIMENTAL | 1000 mcg |
| Cohort 4 | EXPERIMENTAL | Dose to be decided |
| Cohort 5 | EXPERIMENTAL | Dose to be decided |
| 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 |
| PF03635659 | DRUG | Inhaled doses of 200 mcgQD |
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...
PF03635659 is an investigational small molecule developed by Pfizer, Inc. (ticker PFE) for Chronic Obstructive Pulmonary Disease (COPD), a respiratory condition. It has been studied in Phase 2 clinical development. It is also known as Low Dose PF-03635659.
PF03635659 was studied for the treatment of Chronic Obstructive Pulmonary Disease, a chronic respiratory condition. It is an investigational therapy and is not described as an approved treatment. Its clinical program in COPD includes two completed trials, one Phase 2 study in patients and one Phase 1 study in healthy volunteers.
PF03635659 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored both completed clinical trials of the compound, the Phase 2 COPD patient study NCT01033487 and the Phase 1 healthy volunteer study NCT00864786.
PF03635659 is in Phase 2 development. Its clinical program consists of two completed trials: a Phase 2 study in patients with Chronic Obstructive Pulmonary Disease and a Phase 1 multiple dose study in healthy volunteers. No active trials are listed, and the compound is investigational rather than approved.
PF03635659 has been evaluated in two completed trials. NCT01033487 was a Phase 2 study of safety, pharmacokinetics and pharmacodynamics in 22 patients with Chronic Obstructive Pulmonary Disease in Germany. NCT00864786 was a Phase 1 multiple dose safety and pharmacokinetics study in 50 healthy male volunteers in Belgium.
Yes. PF03635659 is also known as Low Dose PF-03635659, so the two names refer to the same investigational compound. Both names describe the Pfizer small molecule studied in Chronic Obstructive Pulmonary Disease across a Phase 2 patient trial and a Phase 1 healthy volunteer trial.