Phase 1
Completed N=32
A Phase 1 Study Of PF-00868554 In Hepatitis C Virus (HCV) Positive Patients
Source: ClinicalTrials.gov NCT00445315 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax): Day 1 — 3467.0; 27437.1; 23046.7; 48392.6 nanogram per milliliter (ng/mL)
Summary
Assess the safety, tolerability and pharmacokinetics of multiple oral doses of PF-00868554 in HCV positive patient volunteers
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax): Day 1 |
3467.0; 27437.1; 23046.7; 48392.6 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax): Day 8 |
5858.8; 33111.4; 30919.1; 57724.5 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax): Day 1 |
1.00; 0.50; 0.51; 0.50 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax): Day 8 |
0.76; 0.50; 0.50; 0.50 | — |
| PRIMARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Day 1 |
13816.6; 73653.0; 52933.7; 110158.1 | — |
| PRIMARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Day 8 |
20632.5; 84983.3; 59492.4; 120849.4 | — |
| PRIMARY Minimum Observed Plasma Trough Concentration (Cmin): Day 8 |
448.6; 904.8; 1055.9; 706.0 | — |
| PRIMARY Plasma Decay Half-Life (t1/2): Day 8 |
12.58; 10.77; 9.17; 8.13 | — |
| PRIMARY Observed Accumulation Ratio (Rac) |
1.49; 1.15; 1.12; 1.09 | — |
| PRIMARY Observed Accumulation Ratio for Cmax (Rac Cmax) |
1.68; 1.20; 1.34; 1.19 | — |
| PRIMARY Cumulative Amount of Drug Recovered Unchanged in Urine (Ae): Day 1 |
13490943.6; 47306427.2; 58500433.1 | — |
| PRIMARY Cumulative Amount of Drug Recovered Unchanged in Urine (Ae): Day 8 |
23157156.8; 61249508.4; 59663120.9 | — |
| PRIMARY Percent of Dose Recovered Unchanged in Urine (Ae%): Day 1 |
13.49; 15.77; 13.00 | — |
| PRIMARY Percent of Dose Recovered Unchanged in Urine (Ae%): Day 8 |
23.16; 20.42; 13.26 | — |
| PRIMARY Renal Clearance (CLr): Day 1 |
16.27; 10.70; 8.85 | — |
| PRIMARY Renal Clearance (CLr): Day 8 |
18.70; 12.01; 8.23 | — |
| PRIMARY Ratio of 6 Beta-Hydroxyl Cortisol to Cortisol: Day 1 |
2.93; 3.94; 4.65; 4.32; 3.56 | — |
| PRIMARY Ratio of 6 Beta-Hydroxyl Cortisol to Cortisol: Day 8 |
3.79; 3.90; 5.26; 4.58; 4.30 | — |
| PRIMARY Day 8 to Day 1 Ratio of the 6 Beta-Hydroxyl Cortisol to Cortisol Ratios |
1.29; 0.99; 1.13; 1.06; 1.20 | — |
| SECONDARY Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Viral Load at Day 8 |
6.14; 6.05; 6.02; 5.75; 6.02; -0.68 | — |
| SECONDARY Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Variants Resistant to PF-00868554 |
0; 6; 2; 3; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00445315). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.