Approval Probability
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Also known as Small Molecule Agent (PF-868554)
Small Molecule Agent · 1 trial · 2 indications
Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (lower limit of quantification \[LLOQ\] = 12 international unit per milliliter \[IU/mL\]). Baseline value calculated as an average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 11 for Cohort A).
Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Baseline value calculated as an average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 11 for Cohort A).
Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Baseline value calculated as an average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 4 for Cohort B).
Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Baseline value calculated as the average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 4 for Cohort B).
Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Change from baseline in plasma Log10 HCV RNA at nadir signified the maximum change observed during the study.
Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Change from baseline in plasma Log10 HCV RNA at nadir signified the maximum change observed during the study.
| Arm | Type | Description |
|---|---|---|
| Cohort B | EXPERIMENTAL | - |
| Cohort A | EXPERIMENTAL | Dose study drug in subjects who have previously failed to respond to interferon based therapies |
| Name | Type | Description |
|---|---|---|
| Small Molecule Agent (PF-868554) | DRUG | Study drug will be administered 700mg BID in the fed state for three days. |
Inclusion Criteria: HCV Positive With HCV RNA\>100,000 iu/ml Genotype 1; COHORT A- non responders or partial Exclusion Criteria: HIV HBV co-infection Decompensated liver disease Liver disease due to causes other than HCV, AFP\>200ng/ml
Small Molecule Agent is an investigational small molecule direct antiviral agent being studied for the treatment of chronic hepatitis C virus infection. It was evaluated in a Phase 1 clinical trial in subjects with chronic HCV infection. It is not approved and remains in clinical development.
Small Molecule Agent is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 study of the compound in chronic hepatitis C virus infection.
Small Molecule Agent is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational agent and has not been approved for any indication.
Small Molecule Agent has been studied in one completed Phase 1 trial, NCT00671671, titled a Phase 1 study to evaluate antiviral activity of a small molecule direct antiviral agent at multiple doses in subjects with chronically infected hepatitis C virus. The trial enrolled 20 participants in the United States.
Yes, Small Molecule Agent is also known as PF-868554. PF-868554 is the compound identifier used by Pfizer for this investigational small molecule direct antiviral agent. Both names refer to the same Phase 1 hepatitis C virus candidate.