Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for the treatment of chronic hepatitis, specifically chronic Hepatitis C Virus infection. It is a direct antiviral agent intended to reduce viral activity in infected subjects. The drug is currently in Phase 1 clinical development and is not yet approved for any use.
Small Molecule Agent is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's antiviral activity in patients with chronic Hepatitis C Virus infection.
Small Molecule Agent is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for its antiviral activity and safety in subjects with chronic Hepatitis C Virus infection, with one completed Phase 1 trial.
Small Molecule Agent has one completed clinical trial, identified as NCT00671671. This Phase 1 study evaluated the antiviral activity of the drug at multiple doses in subjects with chronic Hepatitis C Virus infection. The trial enrolled 20 participants in the United States and was controlled but not randomized or double-blinded.
Small Molecule Agent is described as a small molecule direct antiviral agent. This means it is designed to directly target and inhibit viral replication. In the clinical trial context, it is being evaluated for its antiviral activity against chronic Hepatitis C Virus infection, though specific molecular targets have not been disclosed.