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Phase 1 study in HVC (Hepatitis C Virus) infected subjects to determine pharmacokinetics, safety and efficacy in subjects with no or inadequate response to prior treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort B | Experimental |
| |
| Cohort A | Experimental | Dose study drug in subjects who have previously failed to respond to interferon based therapies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Small Molecule Agent (PF-868554) | Drug | Study drug will be administered 700mg BID in the fed state for three days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 11 (Cohort A): Full Analysis Set | 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). | Baseline, Day 11 |
| Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 11 (Cohort A): Modified Analysis Set | 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). | Baseline, Day 11 |
| Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 4 (Cohort B): Full Analysis Set | 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). | Baseline, Day 4 |
| Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 4 (Cohort B): Modified Analysis Set | 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). | Baseline, Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours. AUCtau was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3). | Predose, 0.5, 1, 2, 6, 8, 12 hours (hrs) postdose on Day 1 for Cohort A and B, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12 hrs post-evening dose on Day 3 for Cohort B, predose, 0.5, 1, 2, 4, 8, 12 hrs postdose on Day 10 for Cohort A |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Gainesville | Florida | 32608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21488067 | Derived | Wagner F, Thompson R, Kantaridis C, Simpson P, Troke PJ, Jagannatha S, Neelakantan S, Purohit VS, Hammond JL. Antiviral activity of the hepatitis C virus polymerase inhibitor filibuvir in genotype 1-infected patients. Hepatology. 2011 Jul;54(1):50-9. doi: 10.1002/hep.24342. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-00868554 450 mg (Cohort A) | Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Small Molecule Agent (PF-868554) | Drug | Study drug will be given 450mg BID for a duration of 10 days. |
|
| Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Nadir: Full Analysis Set | 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. | Baseline, Nadir (lowest HCV RNA level), assessed up to Day 11 for Cohort A and Day 4 for Cohort B |
| Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Nadir: Modified Analysis Set | 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. | Baseline, Nadir (lowest HCV RNA level), assessed up to Day 11 for Cohort A and Day 4 for Cohort B |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the serum concentration time-curve from zero to the last measured concentration (AUClast). AUClast was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3). | Predose, 0.5, 1, 2, 6, 8, 12, 14 hrs postdose on Day 1 for Cohort A, B, pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] | AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) was evaluated at last dose for Cohort A (Day 10) and Cohort B (Day 3). | Pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A |
| Plasma Concentration at The End of Dosing Interval (Ctau) | Ctau was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3). | Predose, 0.5, 1, 2, 6, 8, 12 hours (hrs) postdose on Day 1 for Cohort A and B, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12 hrs post-evening dose on Day 3 for Cohort B, predose, 0.5, 1, 2, 4, 8, 12 hrs postdose on Day 10 for Cohort A |
| Maximum Observed Plasma Concentration (Cmax) | Cmax was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3). | Predose, 0.5, 1, 2, 6, 8, 12, 14 hrs postdose on Day 1 for Cohort A, B, pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Tmax was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3). | Predose, 0.5, 1, 2, 6, 8, 12, 14 hrs postdose on Day 1 for Cohort A, B, pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-life was evaluated at last dose for Cohort A (Day 10) and Cohort B (Day 3). | Pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A |
| FG001 | PF-00868554 700 mg (Cohort B) | Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-00868554 450 mg (Cohort A) | Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state. |
| BG001 | PF-00868554 700 mg (Cohort B) | Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 11 (Cohort A): Full Analysis Set | 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). | Full Analysis Set (FAS) included all randomized participants who took at least 1 dose of study medication and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline, Day 11 |
|
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| ||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 11 (Cohort A): Modified Analysis Set | 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). | Modified Analysis Set (MAS): a subset of FAS which included all participants who had received complete dosage in the corresponding treatment regimen. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline, Day 11 |
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| Primary | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 4 (Cohort B): Full Analysis Set | 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). | FAS included all randomized participants who took at least 1 dose of study medication and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline, Day 4 |
|
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| Primary | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 4 (Cohort B): Modified Analysis Set | 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). | MAS: a subset of FAS which included all participants who had received complete dosage in the corresponding treatment regimen. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline, Day 4 |
|
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| Primary | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Nadir: Full Analysis Set | 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. | FAS included all randomized participants who took at least 1 dose of study medication and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline, Nadir (lowest HCV RNA level), assessed up to Day 11 for Cohort A and Day 4 for Cohort B |
| ||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Nadir: Modified Analysis Set | 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. | MAS: a subset of FAS which included all participants who had received complete dosage in the corresponding treatment regimen. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline, Nadir (lowest HCV RNA level), assessed up to Day 11 for Cohort A and Day 4 for Cohort B |
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| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours. AUCtau was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3). | Per Protocol (PP) analysis set included all participants who took PF-00866554 and had sufficient plasma concentration data to facilitate calculation of the pharmacokinetic (PK) parameters. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. | Posted | Geometric Mean | Standard Deviation | nanogram*hour/milliliter (ng*hr/mL) | Predose, 0.5, 1, 2, 6, 8, 12 hours (hrs) postdose on Day 1 for Cohort A and B, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12 hrs post-evening dose on Day 3 for Cohort B, predose, 0.5, 1, 2, 4, 8, 12 hrs postdose on Day 10 for Cohort A |
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| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the serum concentration time-curve from zero to the last measured concentration (AUClast). AUClast was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3). | PP analysis set. 'N' (number of participants analyzed) = participants evaluable for this measure. 'n' = participants evaluable for this measure at specified time points for each arm, respectively. Given the sampling schedule on Day 1 and Day 10 for 450 mg dose in Cohort A, AUClast data was not considered meaningful and hence were not analyzed. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | Predose, 0.5, 1, 2, 6, 8, 12, 14 hrs postdose on Day 1 for Cohort A, B, pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A |
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| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] | AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) was evaluated at last dose for Cohort A (Day 10) and Cohort B (Day 3). | PP analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are reported for Cohort B at Day 3. Due to differences in sampling schedules between Cohort A and B, AUC (0 - ∞) data was not considered meaningful and hence were not analyzed on Day 10 for Cohort A. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | Pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A |
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| Secondary | Plasma Concentration at The End of Dosing Interval (Ctau) | Ctau was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3). | PP analysis set. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. The Ctau on Day 1 was not necessary for interpretation of the PK data and hence was not analyzed. | Posted | Geometric Mean | Standard Deviation | ng/mL | Predose, 0.5, 1, 2, 6, 8, 12 hours (hrs) postdose on Day 1 for Cohort A and B, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12 hrs post-evening dose on Day 3 for Cohort B, predose, 0.5, 1, 2, 4, 8, 12 hrs postdose on Day 10 for Cohort A |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) | Cmax was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3). | PP analysis set included all participants who took PF-00866554 and had sufficient plasma concentration data to facilitate calculation of the PK parameters. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. | Posted | Geometric Mean | Standard Deviation | ng/mL | Predose, 0.5, 1, 2, 6, 8, 12, 14 hrs postdose on Day 1 for Cohort A, B, pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Tmax was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3). | PP analysis set included all participants who took PF-00866554 and had sufficient plasma concentration data to facilitate calculation of the PK parameters. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. | Posted | Median | Full Range | hours | Predose, 0.5, 1, 2, 6, 8, 12, 14 hrs postdose on Day 1 for Cohort A, B, pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A |
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| Secondary | Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-life was evaluated at last dose for Cohort A (Day 10) and Cohort B (Day 3). | PP analysis set. 'N' (number of participants analyzed) = participants evaluable for this measure. Results are reported for Cohort B at Day 3. Due to limited sampling, time interval over which plasma concentrations were measured after final dose was too short relative to projected t1/2. Therefore, t1/2 estimates were not calculated on Day 10. | Posted | Mean | Standard Deviation | hours | Pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-00868554 450 mg (Cohort A) | Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state. | 0 | 10 | 10 | 10 | ||
| EG001 | PF-00868554 700 mg (Cohort B) | Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state. | 0 | 10 | 7 | 10 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA v11.1 | Non-systematic Assessment |
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| Tinea pedis | Infections and infestations | MedDRA v11.1 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA v11.1 | Non-systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA v11.1 | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D006521 | Hepatitis, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C550357 | filibuvir |
Not provided
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| Title | Measurements |
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| greater than or equal to (>=) 65 years |
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| Male |
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