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Assess the safety, tolerability and pharmacokinetics of multiple oral doses of PF-00868554 in HCV positive patient volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 1 | Experimental |
| |
| 4 | Experimental |
| |
| 5 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-00868554 | Drug | 300 mg BID |
| |
| PF-00868554 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax): Day 1 | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose for twice daily dose; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hours post-dose for three times daily dose | |
| Maximum Observed Plasma Concentration (Cmax): Day 8 | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax): Day 1 | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose for twice daily dose; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hours post-dose for three times daily dose | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax): Day 8 | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose | |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Day 1 | 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. | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose for twice daily dose; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hours post-dose for three times daily dose |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Day 8 | 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. | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Viral Load at Day 8 | HCV RNA levels were determined using the Abbott RealTime HCV polymerase chain reaction (PCR) assay (lower limit of detection [LOD] = 12 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening Day 0 and Day 1 pre-dose measurements. The plasma HCV RNA data was log10 transformed, and the change in log10 HCV RNA at Day 8 post-dose from baseline was calculated. |
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Inclusion Criteria:
Exclusion Criteria:
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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 | Brussels | 1070 | Belgium | |||
| Pfizer Investigational Site |
| 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 100 mg Twice Daily | PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8. |
| FG001 | PF-00868554 300 mg Twice Daily | PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8. |
| FG002 | PF-00868554 300 mg Three Times Daily | PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8. |
| FG003 | PF-00868554 450 mg Twice Daily | PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8. |
| FG004 | Placebo | Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PF-00868554 100 mg Twice Daily | PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8. |
| BG001 | PF-00868554 300 mg Twice Daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Maximum Observed Plasma Concentration (Cmax): Day 1 | Per Protocol (PP) analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the pharmacokinetics (PK) parameters. | Posted | Geometric Mean | Standard Deviation | nanogram per milliliter (ng/mL) | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose for twice daily dose; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hours post-dose for three times daily dose |
|
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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 100 mg Twice Daily | PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA v11.0 | Non-systematic Assessment |
Designation of outcomes as primary, secondary based on team's input. Results for relationship analyses of baseline susceptibility to PF-00868554 and/or non-structural 5B genotype and change in HCV RNA was not done, as per change in planned analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
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| ID | Term |
|---|---|
| C550357 | filibuvir |
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| Drug |
450 mg BID |
|
| PF-00868554 | Drug | 100 mg BID |
|
| PF-00868554 | Drug | 300 mg TID |
|
| Placebo | Drug | Placebo |
|
| Minimum Observed Plasma Trough Concentration (Cmin): Day 8 | The Cmin of PF-04691502 was assessed following repeated oral dose administration for 8 days (multiple dose PK). | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8 |
| Plasma Decay Half-Life (t1/2): Day 8 | 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). | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8 |
| Observed Accumulation Ratio (Rac) | 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). | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 1; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8 |
| Observed Accumulation Ratio for Cmax (Rac Cmax) | Rac Cmax was calculated as, maximum observed plasma concentration on Day 8 (Cmax) divided by maximum observed plasma concentration on Day 1(Cmax). | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 1; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8 |
| Cumulative Amount of Drug Recovered Unchanged in Urine (Ae): Day 1 | 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. | 0 to 12 hours, 12 to 24 hours post-dose |
| Cumulative Amount of Drug Recovered Unchanged in Urine (Ae): Day 8 | 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. | 0 to 12 hours, 12 to 24 hours post-dose |
| Percent of Dose Recovered Unchanged in Urine (Ae%): Day 1 | 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. | 0 to 12 hours, 12 to 24 hours post-dose |
| Percent of Dose Recovered Unchanged in Urine (Ae%): Day 8 | 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. | 0 to 12 hours, 12 to 24 hours post-dose |
| Renal Clearance (CLr): Day 1 | 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. | 0 to 12 hours, 12 to 24 hours post-dose |
| Renal Clearance (CLr): Day 8 | 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. | 0 to 12 hours, 12 to 24 hours post-dose |
| Ratio of 6 Beta-Hydroxyl Cortisol to Cortisol: Day 1 | Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). | -24 to 0 hours (pre-dose) on Day 1 (Day 0) |
| Ratio of 6 Beta-Hydroxyl Cortisol to Cortisol: Day 8 | Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). | 0 to 24 hours post-dose on Day 8 |
| Day 8 to Day 1 Ratio of the 6 Beta-Hydroxyl Cortisol to Cortisol Ratios | Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). | -24 to 0 hours (pre-dose) on Day 1 (Day 0); 0 to 24 hours post-dose on Day 8 |
| Baseline, Day 8 |
| Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Variants Resistant to PF-00868554 | Screening up to Day 8 |
| Berlin |
| 10117 |
| Germany |
| Pfizer Investigational Site | Berlin | 12351 | Germany |
| Pfizer Investigational Site | Dundee | DD1 9SY | United Kingdom |
PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
| BG002 | PF-00868554 300 mg Three Times Daily | PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8. |
| BG003 | PF-00868554 450 mg Twice Daily | PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8. |
| BG004 | Placebo | Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8. |
| BG005 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
| OG002 | PF-00868554 300 mg Three Times Daily | PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8. |
| OG003 | PF-00868554 450 mg Twice Daily | PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8. |
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax): Day 8 | PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. | Posted | Geometric Mean | Standard Deviation | nanogram per milliliter (ng/mL) | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose |
|
|
|
| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax): Day 1 | PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. | Posted | Median | Full Range | hour | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose for twice daily dose; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hours post-dose for three times daily dose |
|
|
|
| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax): Day 8 | PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. | Posted | Median | Full Range | hour | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose |
|
|
|
| Primary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Day 1 | 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. | PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. | Posted | Geometric Mean | Standard Deviation | ng*hour/mL | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose for twice daily dose; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hours post-dose for three times daily dose |
|
|
|
| Primary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Day 8 | 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. | PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. | Posted | Geometric Mean | Standard Deviation | ng*hour/mL | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose |
|
|
|
| Primary | Minimum Observed Plasma Trough Concentration (Cmin): Day 8 | The Cmin of PF-04691502 was assessed following repeated oral dose administration for 8 days (multiple dose PK). | PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. | Posted | Geometric Mean | Standard Deviation | ng/mL | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8 |
|
|
|
| Primary | Plasma Decay Half-Life (t1/2): Day 8 | 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). | PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | hour | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8 |
|
|
|
| Primary | Observed Accumulation Ratio (Rac) | 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). | PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. | Posted | Geometric Mean | Standard Deviation | ratio | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 1; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8 |
|
|
|
| Primary | Observed Accumulation Ratio for Cmax (Rac Cmax) | Rac Cmax was calculated as, maximum observed plasma concentration on Day 8 (Cmax) divided by maximum observed plasma concentration on Day 1(Cmax). | PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. | Posted | Geometric Mean | Standard Deviation | ratio | 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 1; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8 |
|
|
|
| Primary | Cumulative Amount of Drug Recovered Unchanged in Urine (Ae): Day 1 | 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. | PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens. | Posted | Geometric Mean | Standard Deviation | nanogram | 0 to 12 hours, 12 to 24 hours post-dose |
|
|
|
| Primary | Cumulative Amount of Drug Recovered Unchanged in Urine (Ae): Day 8 | 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. | PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens. | Posted | Geometric Mean | Standard Deviation | nanogram | 0 to 12 hours, 12 to 24 hours post-dose |
|
|
|
| Primary | Percent of Dose Recovered Unchanged in Urine (Ae%): Day 1 | 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. | PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens. | Posted | Geometric Mean | Standard Deviation | percent dose recovered | 0 to 12 hours, 12 to 24 hours post-dose |
|
|
|
| Primary | Percent of Dose Recovered Unchanged in Urine (Ae%): Day 8 | 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. | PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens. | Posted | Geometric Mean | Standard Deviation | percent dose recovered | 0 to 12 hours, 12 to 24 hours post-dose |
|
|
|
| Primary | Renal Clearance (CLr): Day 1 | 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. | PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens. | Posted | Geometric Mean | Standard Deviation | mL/minute | 0 to 12 hours, 12 to 24 hours post-dose |
|
|
|
| Primary | Renal Clearance (CLr): Day 8 | 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. | PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens. | Posted | Geometric Mean | Standard Deviation | mL/minute | 0 to 12 hours, 12 to 24 hours post-dose |
|
|
|
| Primary | Ratio of 6 Beta-Hydroxyl Cortisol to Cortisol: Day 1 | Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). | PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. | Posted | Geometric Mean | Standard Deviation | ratio | -24 to 0 hours (pre-dose) on Day 1 (Day 0) |
|
|
|
| Primary | Ratio of 6 Beta-Hydroxyl Cortisol to Cortisol: Day 8 | Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). | PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. | Posted | Geometric Mean | Standard Deviation | ratio | 0 to 24 hours post-dose on Day 8 |
|
|
|
| Primary | Day 8 to Day 1 Ratio of the 6 Beta-Hydroxyl Cortisol to Cortisol Ratios | Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). | PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. | Posted | Geometric Mean | Standard Deviation | ratio | -24 to 0 hours (pre-dose) on Day 1 (Day 0); 0 to 24 hours post-dose on Day 8 |
|
|
|
| Secondary | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Viral Load at Day 8 | HCV RNA levels were determined using the Abbott RealTime HCV polymerase chain reaction (PCR) assay (lower limit of detection [LOD] = 12 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening Day 0 and Day 1 pre-dose measurements. The plasma HCV RNA data was log10 transformed, and the change in log10 HCV RNA at Day 8 post-dose from baseline was calculated. | Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline, Day 8 |
|
|
|
| Secondary | Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Variants Resistant to PF-00868554 | FAS included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | participants | Screening up to Day 8 |
|
|
|
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | PF-00868554 300 mg Twice Daily | PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8. | 0 | 6 | 5 | 6 |
| EG002 | PF-00868554 300 mg Three Times Daily | PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8. | 0 | 6 | 3 | 6 |
| EG003 | PF-00868554 450 mg Twice Daily | PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8. | 0 | 6 | 5 | 6 |
| EG004 | Placebo | Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8. | 0 | 8 | 8 | 8 |
| Foreign body sensation in eyes | Eye disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Change of bowel habit | Gastrointestinal disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Application site erythema | General disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Liver tenderness | Hepatobiliary disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA v11.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA v11.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v11.0 | Non-systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA v11.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA v11.0 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA v11.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Intercostal neuralgia | Nervous system disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Non-systematic Assessment |
|
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.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Change at Day 8 |
|