Clinical trial NCT03309202: Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment
Official title: A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL COHORT STUDY TO COMPARE THE PHARMACOKINETICS OF PF-05221304 IN ADULT SUBJECTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO SUBJECTS WITHOUT HEPATIC IMPAIRMENT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-10-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Hepatic impairment PK study

Detailed description: This is a non randomized, open label, single dose, parallel cohort, multisite study to investigate the effect of varying degrees of hepatic impairment on the plasma pharmacokinetics (total and unbound) of PF-05221304 after a single oral dose administered in the fed state.

Eligibility criteria: Key Exclusion Criteria:

All subjects -

* Adults \<18 years of age and \>70 years of age
* BMI \< 17.5 and \> 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

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of PF-05221304
timeFrame: 0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose
measure: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-05221304
timeFrame: 0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose
measure: Fraction Unbound (fu) of PF-05221304
timeFrame: 4 hours postdose
measure: Unbound Cmax (Cmax,u) of PF-05221304
timeFrame: 4 hours postdose
measure: Unbound AUCinf (AUCinf,u) of PF-05221304
timeFrame: 4 hours postdose
Secondary outcomes:
measure: Time to Reach Maximum Plasma Concentration (Tmax) of PF-05221304
timeFrame: 0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose
measure: Area Under Concentration Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of PF-05221304
timeFrame: 0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose
measure: Unbound AUClast ( AUClast,u) of PF-05221304
timeFrame: 4 hours postdose
measure: Apparent Clearance After Oral Dose (CL/F) of PF-05221304
timeFrame: 0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose
measure: Unbound CL/F (CLu/F) of PF-05221304
timeFrame: 4 hours postdose
measure: Apparent Volume of Distribution After Oral Dose (Vz/F) of PF-05221304
timeFrame: 0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose
measure: Unbound Vz/F (Vz,u/F) of PF-05221304
timeFrame: 4 hours postdose
measure: Terminal Half-Life ( t½) of PF-05221304
timeFrame: 0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Approximately 30 days
measure: Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Hematology
timeFrame: 7 days
measure: Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Clinical Chemistry
timeFrame: 7 days
measure: Number of Paticipants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Urinalysis
timeFrame: 7 days
measure: Number of Participants With Clinical Significant Findings in Vital Signs
timeFrame: 7 days
measure: Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Data
timeFrame: 7 days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
city: Praha 7
country: Czechia
facility: Pharmaceutical Research Associates CZ, s.r.o.
city: Praha 8
country: Czechia
facility: Nemocnice Na Bulovce
city: Bratislava
country: Slovakia
facility: Summit Clinical Research s.r.o.
city: Bratislava
country: Slovakia
facility: Univerzitná Nemocnica Bratislava
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: