Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-04634817 · 5 trials · 3 indications
The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.
AUC (0 - 48)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 48hours.
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
| Arm | Type | Description |
|---|---|---|
| Arm 1 PF-04634817 | ACTIVE_COMPARATOR | - |
| Arm 2 Placebo | PLACEBO_COMPARATOR | - |
| Healthy Volunteers | EXPERIMENTAL | - |
| Mild Renal Impairment | EXPERIMENTAL | - |
| Moderate renal impairment | EXPERIMENTAL | - |
| Severe renal impairment | EXPERIMENTAL | - |
| single dose PF-04634817 tablet | ACTIVE_COMPARATOR | subjects receive a single dose of PF-04634817 as a tablet |
| single dose PF-04634817 solution | ACTIVE_COMPARATOR | subjects receive a single dose of PF-04634817 as a solution |
| Cohort 1 (N=10) | EXPERIMENTAL | Placebo-controlled, multiple doses of PF-04634817 at 3 mg per day for 14 days. (2 placebo: 8 active) |
| Cohort 2 (N=10) | EXPERIMENTAL | Placebo-controlled, multiple doses of PF-04634817 at 3 mg per day for 14 days. (2 placebo: 8 active) |
| Cohort 3 (N=10) | EXPERIMENTAL | Placebo-controlled, multiple doses of PF-04634817 at 30 mg per day for 14 days. (2 placebo: 8 active) |
| Cohort 4 (N=10) | EXPERIMENTAL | Placebo-controlled, multiple doses of PF-04634817 at 100 mg per day for 14 days. (2 placebo: 8 active) |
| Cohort 5 (N=10) | EXPERIMENTAL | Placebo-controlled, multiple doses of PF-04634817 at 300 mg per day for 14 days. (2 placebo: 8 active) |
| Cohort 6 (N=10) Optional cohort | EXPERIMENTAL | Placebo-controlled, multiple doses of PF-04634817 up to 300 mg per day for 14 days. (2 placebo: 8 active) |
| Placebo | PLACEBO_COMPARATOR | - |
| Cohort 1, 1mg | EXPERIMENTAL | - |
| Cohort 1, 3mg | EXPERIMENTAL | - |
| Cohort 1, 10mg | EXPERIMENTAL | - |
| Cohort 2, 30mg | EXPERIMENTAL | - |
| Cohort 2, 100mg | EXPERIMENTAL | - |
| Cohort 2, 300mg | EXPERIMENTAL | - |
| Cohort 3, 600mg | EXPERIMENTAL | - |
| Cohort 3, 900mg | EXPERIMENTAL | - |
| Cohort 3, up to 900mg (fed) | EXPERIMENTAL | - |
| Cohort 3, placebo (fed) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-04634817 | DRUG | Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function |
| Placebo | DRUG | Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function |
| PF-04634817 Placebo | DRUG | Oral solution, placebo, single dose |
Inclusion Criteria: * Clinical diagnosis of type 2 diabetes together with stages 2, 3a, 3b or 4 CKD, based on an eGFR of 20-75 mL/min/1.73m2. * Evidence of persistent, overt albuminuria; defined as a UACR \>=300 mg/g (\>=33.9 mg/mmol) or UPCR \>=390 mg/g (44.1 mg/mmol), or equivalent, for 3 months ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| DexCom, Inc. | DXCM | 1 | PHASE3 | Sotagliflozin |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | ALN-ANG3, Evinacumab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | Atrasentan |
| ProKidney Corp. Class A | PROK | 2 | - | Renal Autologous Cell Therapy |
PF-04634817 is an investigational small molecule being studied for diabetic nephropathy in adults with type 2 diabetes and overt nephropathy. It has also been evaluated in healthy volunteers and in people with renal insufficiency. It is not approved and remains in clinical development.
PF-04634817 is a chemokine CCR2/5 receptor antagonist, as described in its Phase 2 trial title. It targets the CCR2 and CCR5 receptors, which are involved in inflammatory processes relevant to diabetic nephropathy.
PF-04634817 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company sponsored the clinical trials for this investigational small molecule.
PF-04634817 is in Phase 2 clinical development. Its Phase 2 trial in diabetic nephropathy has been completed. The drug is investigational and has not been approved by regulatory authorities.
PF-04634817 has completed three Phase 1 trials in healthy volunteers: NCT01098877, NCT01140672, and NCT01247883. It also completed a Phase 2 trial, NCT01712061, in adults with type 2 diabetes and overt nephropathy. All trials are completed.
No alternative names for PF-04634817 have been disclosed. It is referred to solely by its compound identifier PF-04634817 in clinical trial records and by its developer, Pfizer.