Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PH-797804 · 11 trials · 7 indications
ACR20 responders: participants with greater than or equal to(\>=)20% improvement in tender and swollen 28-joint counts from baseline, \>=20% improvement in at least 3 of 5 measures: Patient's global assessment of arthritis(PGA), physician's global assessment of arthritis, participant's assessment of pain on visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI), C-reactive protein (CRP) in mg/liter (mg/L). PGA:participant assess overall disease activity on VAS, score:0(no arthritis) to 100(extreme arthritis), high score=more arthritis. Physician's global assessment:physician judge participant's overall disease activity on VAS, score:0(no arthritis) to 100millimeter(mm) (extreme arthritis), high score=more arthritis. Pain-VAS:participant assess arthritis pain on 100mm VAS, score:0mm (no pain) to 100mm (extreme pain), high score=more pain. HAQ-DI:functional disability evaluation, score:0 (no difficulty) to 3 (unable to do), high score=more disability.
QT interval corrected for heart rate using Fredericias correction
Neutrophil \& Macrophage count (total and differential)
TNF-α, MIP-1β, IL-6, MPO, MCP-1, GRO-α
| Arm | Type | Description |
|---|---|---|
| PH-787904 (arm1) | EXPERIMENTAL | - |
| PH-787904 (arm2) | EXPERIMENTAL | - |
| PH-787904 (arm3) | EXPERIMENTAL | - |
| PH-787904 (arm4) | EXPERIMENTAL | - |
| PH-787904 (arm5) | EXPERIMENTAL | - |
| Placebo | EXPERIMENTAL | - |
| PH-797804 | EXPERIMENTAL | - |
| Treatment Sequence 1 | OTHER | - |
| Treatment Sequence 2 | OTHER | - |
| Treatment Sequence 3 | OTHER | - |
| Treatment Sequence 4 | OTHER | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| 5 | EXPERIMENTAL | - |
| Moxifloxacin | EXPERIMENTAL | Subjects will receive a single 400 mg dose in the fed state |
| PH-797804 6 mg | EXPERIMENTAL | Subjects will receive a single 6 mg dose in the fed state |
| PH-797804 6 mg + erythromycin 800 mg | EXPERIMENTAL | Subjects will receive multiple 800 mg doses of erythromycin and a single 6 mg dose of PH-797804 in the fed state |
| PH-797804 1 mg Fasted | EXPERIMENTAL | Subjects will receive a single 1 mg dose in the fasted state |
| PH-797804 1 mg Fed | EXPERIMENTAL | Subjects will receive a single 1 mg dose following a high-fat meal |
| PH-797804 10 mg Fasted | EXPERIMENTAL | Subjects will receive a single 10 mg dose in the fasted state |
| PH-797804 10 mg Fed | EXPERIMENTAL | Subjects will receive a single 10 mg dose following a high-fat meal |
| PH-797804 24 mg Fed | EXPERIMENTAL | Subjects will receive a single 24 mg dose following a high-fat meal |
| Arm A | EXPERIMENTAL | - |
| Arm B | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PH-797804 | DRUG | 0.25 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks |
| Placebo | DRUG | Placebo oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks |
| Naproxen | DRUG | Tablet, 500 mg twice daily for 2 weeks |
| Naproxen + PH-797804 | DRUG | Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks |
| Moxifloxacin | DRUG | Tablet, 400 mg, single dose |
| PH-797804 + erythromycin | DRUG | PH-797804: tablet, 6mg, single erythromycin: tablet, 400 mg, multiple |
Inclusion Criteria: * Male or female subjects between, and including, the ages of 40 and 80 years. * Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease: Subjects must have a post-bronchodilator FEV1/FVC ratio \<0.7 ...
PH-797804 is an investigational small molecule being developed by Pfizer for the treatment of chronic obstructive pulmonary disease (COPD). It has been studied in a Phase 2 trial in adults with moderate to severe COPD, and it is also being evaluated in healthy volunteer studies. The drug is not approved and remains in clinical development.
PH-797804 is a small molecule that targets p38 MAP kinase, an enzyme involved in inflammatory signaling. By inhibiting this target, the drug is intended to reduce inflammation in conditions like COPD. This mechanism was studied in a Phase 2 trial for COPD and in healthy volunteer studies.
PH-797804 is developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker PFE. Pfizer has conducted clinical trials of PH-797804 in multiple countries, including the United States, for the treatment of chronic obstructive pulmonary disease.
PH-797804 has completed Phase 2 clinical development for chronic obstructive pulmonary disease. It has also completed Phase 1 studies in healthy volunteers. The drug is investigational and has not received FDA approval. All three clinical trials for PH-797804 have been completed, with no active trials currently ongoing.
PH-797804 has been studied in three completed clinical trials. The Phase 2 trial NCT01543919 evaluated its efficacy and safety in 730 adults with moderate to severe COPD. Phase 1 trials include NCT01589614, which studied its interaction with erythromycin in 12 healthy subjects, and NCT01862887, which assessed its effect on QTc interval in 48 healthy volunteers.
PH-797804 is a distinct investigational compound developed by Pfizer. It is not known to be the same as any other marketed drug. Its development has focused on chronic obstructive pulmonary disease, and it has been studied in clinical trials under its own name, PH-797804.