Clinical trial NCT00445315: A Phase 1 Study Of PF-00868554 In Hepatitis C Virus (HCV) Positive Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax): Day 1
timeFrame: 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
measure: Maximum Observed Plasma Concentration (Cmax): Day 8
timeFrame: 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax): Day 1
timeFrame: 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
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax): Day 8
timeFrame: 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Day 1
timeFrame: 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
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Day 8
timeFrame: 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose
measure: Minimum Observed Plasma Trough Concentration (Cmin): Day 8
timeFrame: 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
measure: Plasma Decay Half-Life (t1/2): Day 8
timeFrame: 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
measure: Observed Accumulation Ratio (Rac)
timeFrame: 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
measure: Observed Accumulation Ratio for Cmax (Rac Cmax)
timeFrame: 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
measure: Cumulative Amount of Drug Recovered Unchanged in Urine (Ae): Day 1
timeFrame: 0 to 12 hours, 12 to 24 hours post-dose
measure: Cumulative Amount of Drug Recovered Unchanged in Urine (Ae): Day 8
timeFrame: 0 to 12 hours, 12 to 24 hours post-dose
measure: Percent of Dose Recovered Unchanged in Urine (Ae%): Day 1
timeFrame: 0 to 12 hours, 12 to 24 hours post-dose
measure: Percent of Dose Recovered Unchanged in Urine (Ae%): Day 8
timeFrame: 0 to 12 hours, 12 to 24 hours post-dose
measure: Renal Clearance (CLr): Day 1
timeFrame: 0 to 12 hours, 12 to 24 hours post-dose
measure: Renal Clearance (CLr): Day 8
timeFrame: 0 to 12 hours, 12 to 24 hours post-dose
measure: Ratio of 6 Beta-Hydroxyl Cortisol to Cortisol: Day 1
timeFrame: -24 to 0 hours (pre-dose) on Day 1 (Day 0)
measure: Ratio of 6 Beta-Hydroxyl Cortisol to Cortisol: Day 8
timeFrame: 0 to 24 hours post-dose on Day 8
measure: Day 8 to Day 1 Ratio of the 6 Beta-Hydroxyl Cortisol to Cortisol Ratios
timeFrame: -24 to 0 hours (pre-dose) on Day 1 (Day 0); 0 to 24 hours post-dose on Day 8
Secondary outcomes:
measure: Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Viral Load at Day 8
timeFrame: Baseline, Day 8
measure: Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Variants Resistant to PF-00868554
timeFrame: Screening up to Day 8
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.