Hepatitis CPhase 1NCT00445315

A Phase 1 Study Of PF-00868554 In Hepatitis C Virus (HCV) Positive Patients

A Phase 1 study testing PF-00868554 in people with Hepatitis C, run by Pfizer at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Assess the safety, tolerability and pharmacokinetics of multiple oral doses of PF-00868554 in HCV positive patient volunteers Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hepatitis C
What is being tested?: PF-00868554
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 4 sitesin 3 countries
Study dates: Jan 2007to Jun 2008
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

HCV RNA ≥ 100,000 IU/mL at screening
Genotype 1a or 1b

Who cannot join

Current or prior treatment with IFN and/or RBV
Evidence of decompensated liver disease

Trial locations and contacts

4 sites in 3 countries.

Country

City, postcode or hospital

4 sites in 3 countries

Germany2 sites

Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Berlin, 12351

Other trials in Germany

Belgium1 site

Pfizer Investigational Site
Brussels, 1070

Other trials in Belgium

United Kingdom1 site

Pfizer Investigational Site
Dundee, DD1 9SY

Other trials in United Kingdom

About this study

Official title: A Phase 1, Randomized, Double Blind (3rd Party Open), Placebo-controlled, Sequential Group, Multicentre Study To Evaluate The Multiple Dose Safety, Tolerability, Pharmacokinetics And Pharmacodynamics, of PF-00868554 in Hepatitis C Virus (HCV) Positive Otherwise Healthy Patient Volunteers

Assess the safety, tolerability and pharmacokinetics of multiple oral doses of PF-00868554 in HCV positive patient volunteers

Conditions: Hepatitis C
Being tested: PF-00868554, Placebo
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-00868554Drug
300 mg BID
PF-00868554Drug
450 mg BID
PF-00868554Drug
100 mg BID
PF-00868554Drug
300 mg TID
PlaceboDrug
Placebo

Study groups in NCT00445315
Study group	Role	What they receive
2	Experimental	Not described Receives: Drug: PF-00868554
3	Experimental	Not described Receives: Drug: PF-00868554
1	Experimental	Not described Receives: Drug: PF-00868554
4	Experimental	Not described Receives: Drug: PF-00868554
5	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax): Day 1
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: -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).
Measured: 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).
Measured: -24 to 0 hours (pre-dose) on Day 1 (Day 0); 0 to 24 hours post-dose on Day 8

Secondary outcomes (2)

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.
Measured: Baseline, Day 8
Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Variants Resistant to PF-00868554
Measured: Screening up to Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Jun 2008

First posted8 Mar 2007 (estimated)
Study startJan 2007
Primary completionJun 2008
Study completionJun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis CStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00445315
Sponsor's protocol ID: A8121002
Status last verified: Jan 2014
First submitted: 6 Mar 2007
Last updated: 17 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 21488067

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double Blind (3rd Party Open), Placebo-controlled, Sequential Group, Multicentre Study To Evaluate The Multiple Dose Safety, Tolerability, Pharmacokinetics And Pharmacodynamics, of PF-00868554 in Hepatitis C Virus (HCV) Positive Otherwise Healthy Patient Volunteers
ClinicalTrials.gov ID: NCT00445315
Acronym / sponsor ID: A8121002
Conditions: Hepatitis C
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 8 Mar 2007 (estimated)
Results: Posted 17 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Assess the safety, tolerability and pharmacokinetics of multiple oral doses of PF-00868554 in HCV positive patient volunteers

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
2	Experimental	Drug: PF-00868554
3	Experimental	Drug: PF-00868554
1	Experimental	Drug: PF-00868554
4	Experimental	Drug: PF-00868554
5	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

HCV RNA ≥ 100,000 IU/mL at screening
Genotype 1a or 1b

Key exclusion criteria (2 listed)

Current or prior treatment with IFN and/or RBV
Evidence of decompensated liver disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-00868554300 mg BID	Drug	1
PF-00868554450 mg BID	Drug	2
PF-00868554100 mg BID	Drug	3
PF-00868554300 mg TID	Drug	4
PlaceboPlacebo	Drug	5

Primary outcome

Maximum Observed Plasma Concentration (Cmax): Day 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 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 Curve From Time Zero to End of Dosing Interval (AUCtau): Day 8
Time frame: 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 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.
Minimum Observed Plasma Trough Concentration (Cmin): Day 8
Time frame: 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
The Cmin of PF-04691502 was assessed following repeated oral dose administration for 8 days (multiple dose PK).
Plasma Decay Half-Life (t1/2): Day 8
Time frame: 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 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).
Observed Accumulation Ratio (Rac)
Time frame: 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
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).
Observed Accumulation Ratio for Cmax (Rac Cmax)
Time frame: 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
Rac Cmax was calculated as, maximum observed plasma concentration on Day 8 (Cmax) divided by maximum observed plasma concentration on Day 1(Cmax).
Cumulative Amount of Drug Recovered Unchanged in Urine (Ae): Day 1
Time frame: 0 to 12 hours, 12 to 24 hours post-dose
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.
Cumulative Amount of Drug Recovered Unchanged in Urine (Ae): Day 8
Time frame: 0 to 12 hours, 12 to 24 hours post-dose
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 (Ae%): Day 1
Time frame: 0 to 12 hours, 12 to 24 hours post-dose
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 (Ae%): Day 8
Time frame: 0 to 12 hours, 12 to 24 hours post-dose
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 (CLr): Day 1
Time frame: 0 to 12 hours, 12 to 24 hours post-dose
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 (CLr): Day 8
Time frame: 0 to 12 hours, 12 to 24 hours post-dose
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.
Ratio of 6 Beta-Hydroxyl Cortisol to Cortisol: Day 1
Time frame: -24 to 0 hours (pre-dose) on Day 1 (Day 0)
Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).
Ratio of 6 Beta-Hydroxyl Cortisol to Cortisol: Day 8
Time frame: 0 to 24 hours post-dose on Day 8
Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).
Day 8 to Day 1 Ratio of the 6 Beta-Hydroxyl Cortisol to Cortisol Ratios
Time frame: -24 to 0 hours (pre-dose) on Day 1 (Day 0); 0 to 24 hours post-dose on Day 8
Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).

2 secondary outcomes

Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Viral Load at Day 8
Time frame: Baseline, Day 8
Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Variants Resistant to PF-00868554
Time frame: Screening up to Day 8

Results and safety

Results posted to the registry on 17 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PF-00868554 100 mg Twice Daily	6	6
PF-00868554 300 mg Twice Daily	6	6
PF-00868554 300 mg Three Times Daily	6	6
PF-00868554 450 mg Twice Daily	6	6
Placebo	8	8

Primary outcome: Maximum Observed Plasma Concentration (Cmax): Day 1

Time frame: 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. Geometric mean (Standard Deviation). Unit: nanogram per milliliter (ng/mL)

Measure	PF-00868554 100 mg Twice Daily n = 6	PF-00868554 300 mg Twice Daily n = 6	PF-00868554 300 mg Three Times Daily n = 6	PF-00868554 450 mg Twice Daily n = 6
Value	3467.0 (1085.36)	27437.1 (7875.45)	23046.7 (10526.66)	48392.6 (13466.65)

Population analysed: 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.

Primary outcome: Maximum Observed Plasma Concentration (Cmax): Day 8

Time frame: 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose. Geometric mean (Standard Deviation). Unit: nanogram per milliliter (ng/mL)

Measure	PF-00868554 100 mg Twice Daily n = 6	PF-00868554 300 mg Twice Daily n = 6	PF-00868554 300 mg Three Times Daily n = 6	PF-00868554 450 mg Twice Daily n = 6
Value	5858.8 (2312.65)	33111.4 (8680.94)	30919.1 (6576.52)	57724.5 (17739.87)

Population analysed: PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.

Primary outcome: Time to Reach Maximum Observed Plasma Concentration (Tmax): Day 1

Measure	PF-00868554 100 mg Twice Daily n = 6	PF-00868554 300 mg Twice Daily n = 6	PF-00868554 300 mg Three Times Daily n = 6	PF-00868554 450 mg Twice Daily n = 6
Value	1.00 (0.50 to 1.50)	0.50 (0.50 to 1.00)	0.51 (0.50 to 1.00)	0.50 (0.50 to 1.03)

Population analysed: PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.

Primary outcome: Time to Reach Maximum Observed Plasma Concentration (Tmax): Day 8

Time frame: 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose. Median (Full Range). Unit: hour

Measure	PF-00868554 100 mg Twice Daily n = 6	PF-00868554 300 mg Twice Daily n = 6	PF-00868554 300 mg Three Times Daily n = 6	PF-00868554 450 mg Twice Daily n = 6
Value	0.76 (0.50 to 1.00)	0.50 (0.50 to 1.00)	0.50 (0.48 to 0.50)	0.50 (0.48 to 0.52)

Population analysed: PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-00868554 100 mg Twice Daily	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
PF-00868554 300 mg Twice Daily	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
PF-00868554 300 mg Three Times Daily	0 of 6 (0%)	3 of 6 (50%)	Not reported
PF-00868554 450 mg Twice Daily	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Placebo	0 of 8 (0%)	8 of 8 (100%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21488067Wagner 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

4 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-00868554 in people with Hepatitis C, run by Pfizer at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany, Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax): Day 1 (time frame: 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). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00445315, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2014.