Phase 1
N=24
Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment
Hepatic Impairment
Bottom Line
View on ClinicalTrials.gov: NCT03309202 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Maximum Plasma Concentration (Cmax) of PF-05221304 — 1220; 1591; 1433; 1592 Nanogram per milliliter (ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-05221304 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) of PF-05221304 |
1220; 1591; 1433; 1592 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-05221304 |
17520; 23890; 21770; 20790 | — |
| PRIMARY Fraction Unbound (fu) of PF-05221304 |
0.005519; 0.006883; 0.008117; 0.01240 | — |
| PRIMARY Unbound Cmax (Cmax,u) of PF-05221304 |
6.731; 10.94; 11.63; 19.74 | — |
| PRIMARY Unbound AUCinf (AUCinf,u) of PF-05221304 |
96.78; 164.4; 176.6; 257.7 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) of PF-05221304 |
4.01; 4.95; 4.50; 4.00 | — |
| SECONDARY Area Under Concentration Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of PF-05221304 |
17400; 23670; 21680; 20700 | — |
| SECONDARY Unbound AUClast ( AUClast,u) of PF-05221304 |
96.07; 163.3; 175.9; 256.7 | — |
| SECONDARY Apparent Clearance After Oral Dose (CL/F) of PF-05221304 |
1.427; 1.048; 1.151; 1.202 | — |
| SECONDARY Unbound CL/F (CLu/F) of PF-05221304 |
258.7; 152.0; 141.6; 97.02 | — |
| SECONDARY Apparent Volume of Distribution After Oral Dose (Vz/F) of PF-05221304 |
34.94; 24.53; 23.16; 23.97 | — |
| SECONDARY Unbound Vz/F (Vz,u/F) of PF-05221304 |
6334; 3563; 2854; 1931 | — |
| SECONDARY Terminal Half-Life ( t½) of PF-05221304 |
17.43; 17.25; 14.30; 14.76 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
0; 1; 2; 0; 0; 1 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Hematology |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Clinical Chemistry |
0; 0; 1; 5; 0; 0 | — |
| SECONDARY Number of Paticipants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Urinalysis |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinical Significant Findings in Vital Signs |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Data |
0; 0; 0; 0 | — |
Summary
Hepatic impairment PK study
Eligibility Criteria
Key Exclusion Criteria
All subjects -
- Adults 70 years of age
- BMI 35.4 kg/m2
- HIV positive
- Conditions that affect drug absorption
- Positive breath alcohol test
Healthy/ those without hepatic impairment -
- Known or suspected hepatic impairment
- Evidence of Hepatitis B or C
- On any chronic medications
Those with varying degrees of hepatic impairment -
- Not meeting Classification A, B, or C of hepatic impairment based on Child-Pugh Classification
- Evidence of Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy
- Recent GI bleed
- Moderate or severe renal impairment
- Hepatic encephalopathy Grade 3 or higher
Data sourced from ClinicalTrials.gov (NCT03309202). 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.