Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]-PF-00868554
PF-00868554 · 3 trials · 2 indications
Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 international unit per milliliter \[IU/mL\]). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.
Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.
Area under the plasma concentration time-curve from time zero to end of dosing interval (tau), where dosing interval is 8 hours for three times daily regimens and 12 hours for the twice daily regimens.
Area under the plasma concentration time-curve from time zero to end of dosing interval (tau), where dosing interval is 8 hours for three times daily regimens and 12 hours for the twice daily regimens.
The Cmin of PF-04691502 was assessed following repeated oral dose administration for 8 days (multiple dose PK).
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. The t1/2 of PF-04691502 was assessed following repeated oral dose administration for 8 days (multiple dose PK).
Rac was calculated as, area under the curve from time zero to end of dosing interval on Day 8 (AUCtau) divided by area under the curve from time zero to end of dosing interval on Day 1(AUCtau).
Rac Cmax was calculated as, maximum observed plasma concentration on Day 8 (Cmax) divided by maximum observed plasma concentration on Day 1(Cmax).
Ae is the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval is 12 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram \[g\]/1.020), where 1.020 g/mL is the approximate specific gravity of urine.
Ae is the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval is 12 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram \[g\]/1.020), where 1.020 g/mL is the approximate specific gravity of urine.
Percent of dose recovered unchanged in urine during the dosing interval=100\*(cumulative amount of drug recovered unchanged in urine \[Ae\] divided by dose), where the dosing interval is 12 hours.
Percent of dose recovered unchanged in urine during the dosing interval=100 (cumulative amount of drug recovered unchanged in urine \[Ae\] divided by dose), where the dosing interval is 12 hours.
Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval is 12 hours.
Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval is 12 hours.
Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).
Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).
Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | 500 mg BID |
| B | EXPERIMENTAL | 300 mg BID |
| C | EXPERIMENTAL | 200 mg BID |
| D | PLACEBO_COMPARATOR | Placebo |
| 1 | EXPERIMENTAL | \[14C\]-PF-00868554 |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| 5 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-00868554 | DRUG | 500 mg BID administered as 5x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks. |
| Placebo | DRUG | Placebo administered for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks |
| [14C]-PF-00868554 | DRUG | solution, single dose |
Inclusion Criteria: * Treatment naive (no prior treatment with IFN-a +/- RBV regimens. * Subjects who have discontinued IFN-a containing regimens after \<2 weeks of therapy due to tolerability issues are considered treatment naive. * HCV RNA \> 100,000 IU/mL at screening. * Genotype 1. * A diagnosi...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir |
PF-00868554 is an investigational small molecule developed for the treatment of hepatitis C virus (HCV) infection. It has been studied in patients with chronic hepatitis C, including genotype 1 infection, and in healthy volunteers. It is not an approved therapy and remains in clinical development.
PF-00868554 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical studies of the compound in hepatitis C patients and healthy volunteers.
PF-00868554 is in Phase 1 development, with a Phase 2 dose ranging study also completed. It is an investigational agent and has not been approved by the FDA for any indication. All listed trials are completed, and no trials are currently active.
PF-00868554 has been evaluated in three completed trials: NCT00823745, a radiolabeled ADME study in healthy adult males; NCT00720434, a Phase 2 dose ranging study in combination with PEGASYS and COPEGUS in chronic hepatitis C genotype 1 patients; and NCT00445315, a Phase 1 study in HCV positive patients.
Yes, [14C]-PF-00868554 is an alternative name for PF-00868554. The [14C] label denotes a carbon-14 radiolabeled version of the compound used in a radiolabel ADME study (NCT00823745) to track absorption, distribution, metabolism, and excretion in healthy adult male subjects.