A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT04193436
Collaborator
(none)
23
3
4
17.6
7.7
0.4

Study Details

Study Description

Brief Summary

The study is proposed to characterize the effect of varying degrees of hepatic impairment on the plasma PK of PF-06835919

Condition or Disease Intervention/Treatment Phase
  • Drug: PF-06835919 25 mg
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL-COHORT STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT
Actual Study Start Date :
Jan 21, 2020
Actual Primary Completion Date :
Jul 9, 2021
Actual Study Completion Date :
Jul 9, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: PF-06835919 with severe hepatic impairement

This arm includes participants with severe hepatic impairment who will receive a 25mg oral dose of PF-06835919

Drug: PF-06835919 25 mg
PF-06835919 in 25 mg oral tablet will be administered on Day 1

Experimental: PF-06835919 with moderate hepatic impairement

This arm includes participants with moderate hepatic impairment who will receive a 25mg oral dose of PF-06835919

Drug: PF-06835919 25 mg
PF-06835919 in 25 mg oral tablet will be administered on Day 1

Experimental: PF-06835919 with mild hepatic impairement

This arm includes participants with mild hepatic impairment who will receive a 25mg oral dose of PF-06835919

Drug: PF-06835919 25 mg
PF-06835919 in 25 mg oral tablet will be administered on Day 1

Experimental: PF-06835919 without hepatic impairment

This arm includes participants without hepatic impairment who will receive a 25mg oral dose of PF-06835919

Drug: PF-06835919 25 mg
PF-06835919 in 25 mg oral tablet will be administered on Day 1

Outcome Measures

Primary Outcome Measures

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[inf]) [Hour 0, 0.5, 1, 2, 4, 6, 8, 10, 12 on Day 1, Hour 24, 36 on Day 2, Hour 48 on Day 3, Hour 72 on Day 4, Hour 96 on Day 5, Hour 120 on Day 6]

  2. Maximum Plasma Concentration (C[max]) [Hour 0, 0.5, 1, 2, 4, 6, 8, 10, 12 on Day 1, Hour 24, 36 on Day 2, Hour 48 on Day 3, Hour 72 on Day 4, Hour 96 on Day 5, Hour 120 on Day 6]

  3. Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[inf,u]) [Hour 2 on Day 1]

  4. Unbound Maximum Plasma Concentration (C[max,u]) [Hour 2 on Day 1]

  5. Fraction of Drug Unbound (f[u]) [Hour 2 on Day 1]

Secondary Outcome Measures

  1. Number of Participantss Reporting Treatment-emergent AEs [Baseline (Day 1) up to 30 days after last dose of study medication]

  2. Number of Participants with Clinically Significant Change from Baseline in Laboratory Tests [Baseline (Day 1) up to 30 days after last dose of study medication]

  3. Number of Participants with Clinically Significant Change from Baseline in Vital Signs [Baseline (Day 1) up to 30 days after last dose of study medication]

  4. Njumber of Participants with Clinically Significant Change from Baseline in 12-Lead ECGs [Baseline (Day 1) up to 30 days after last dose of study medication]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Male and female participants between the ages of 18 (or the minimum country specific age of consent if >18) and 70 years, inclusive, at the Screening visit:

  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

  • Body mass index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg (110 lb).

  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.

Exclusion Criteria:
  • Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection).

(Participants who have undergone cholecystectomy and/or appendectomy are eligible for this study as long as the surgery occurred more than 6 months prior to Screening)..

  • At Screening, participants with a positive result for human immunodeficiency virus (HIV) antibodies, as assessed by sponsor identified central laboratory, with a single repeat permitted to assess eligibility, if needed.

  • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behaviour or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

  • Use of prior/concomitant therapies.

  • Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product used in this study (whichever is longer).

  • Participants with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF 06835919.

  • A positive urine drug test, for illicit drugs, and/or a positive breath alcohol test at Screening. However, participants who have been medially prescribed opiates/opiods or benzodiazepines and report the use of these drugs to the investigator at the screening visit will be allowed to participate.

  • Male participants with partners who are currently pregnant.

  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing and until the follow-up contact.

  • History of sensitivity to heparin or heparin induced thrombocytopenia, only if heparin is used to flush intravenous catheters used during serial blood collections.

  • Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of the protocol.

  • Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brussels Clinical Research Unit Brussels Bruxelles-capitale, RĂ©gion DE Belgium B-1070
2 Pharmaceutical Research Associates CZ, s.r.o. Praha 7 Czechia 170 00
3 Summit Clinical Research, s.r.o., Bratislava Slovakia 83101

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04193436
Other Study ID Numbers:
  • C1061013
  • HEPATIC IMPAIRMENT
  • 2019-003480-21
First Posted:
Dec 10, 2019
Last Update Posted:
Aug 12, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pfizer
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2021