Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment

NCT03309202 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: C11710062017-003034-86
• Study Type: interventional
• Target: 24
• Locations: 4 countries
• Sites: 6

Brief Summary

Hepatic impairment PK study

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (5)

• Maximum Plasma Concentration (Cmax) of PF-05221304

  Cmax was observed directly from data.

  0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose

• Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-05221304

  AUCinf was calculated by AUClast + (Clast\*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

  0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose

• Fraction Unbound (fu) of PF-05221304

  fu was the fraction of PF-05221304 unbound in plasma. fu was calculated based on the post-dialysis plasma concentrations, post-dialysis buffer concentrations, collected post-dialysis plasma and post-dialysis buffer sample volume (assuming no volume shift prior to and after dialysis), and the total plasma concentrations.

  4 hours postdose

• Unbound Cmax (Cmax,u) of PF-05221304

  Cmax,u was calculated by fu\*Cmax.

  4 hours postdose

• Unbound AUCinf (AUCinf,u) of PF-05221304

  AUCinf,u was calculated by fu\*AUCinf.

  4 hours postdose

Secondary Outcomes (14)

• Time to Reach Maximum Plasma Concentration (Tmax) of PF-05221304

  0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose

• Area Under Concentration Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of PF-05221304

  0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose

• Unbound AUClast ( AUClast,u) of PF-05221304

  4 hours postdose

• Apparent Clearance After Oral Dose (CL/F) of PF-05221304

  0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose

• Unbound CL/F (CLu/F) of PF-05221304

  4 hours postdose

Study Arms (4)

Cohort 1_Without impairment

EXPERIMENTAL

Single, 25 mg dose of PF-05221304

Drug: PF-05221304

Cohort 2_Mild impairment

EXPERIMENTAL

Single, 25 mg dose of PF-05221304

Drug: PF-05221304

Cohort 3_Moderate impairment

EXPERIMENTAL

Single, 25 mg dose of PF-05221304

Drug: PF-05221304

Cohort 4_Severe impairment

EXPERIMENTAL

Single, 25 mg dose of PF-05221304

Drug: PF-05221304

Interventions

PF-05221304 DRUG

25 mg dose

Also known as: experimental drug

Cohort 1_Without impairment; Cohort 2_Mild impairment; Cohort 3_Moderate impairment; Cohort 4_Severe impairment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (6)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Pharmaceutical Research Associates CZ, s.r.o.

Prague, 170 00, Czechia

Location

Nemocnice Na Bulovce

Prague, 180 81, Czechia

Location

Summit Clinical Research s.r.o.

Bratislava, 83101, Slovakia

Location

Univerzitná Nemocnica Bratislava

Bratislava, 83305, Slovakia

Location

Related Links

• To obtain contact information for a study center near you, click here.
• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Drugs, Investigational

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer,Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 13, 2017
• Study Start: December 19, 2017
• Primary Completion: June 26, 2018
• Study Completion: July 18, 2018
• Last Updated: August 8, 2019
• Results First Posted: August 8, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); BE (1); CZ (2); SL (2)