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Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT04091061
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma PK of PF-06865571.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Healthy Volunteers Drug: PF-06865571 100 mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 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-06865571 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT
Estimated Study Start Date : September 19, 2019
Estimated Primary Completion Date : June 14, 2020
Estimated Study Completion Date : June 14, 2020


Arm Intervention/treatment
Experimental: PF-06865571 Moderate Hepatic Impairment
This arm includes participants with moderate hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1
Drug: PF-06865571 100 mg
PF-06865571 in 100 mg oral tablet will be administered on Day 1

Experimental: PF-06865571 Severe Hepatic Impairment
This arm includes participants with severe hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1
Drug: PF-06865571 100 mg
PF-06865571 in 100 mg oral tablet will be administered on Day 1

Experimental: PF-06865571 Mild Hepatic Impairment
This arm includes participants with mild hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1
Drug: PF-06865571 100 mg
PF-06865571 in 100 mg oral tablet will be administered on Day 1

Experimental: PF-06865571 Healthy Participants
This arm includes healthy participants who will receive an oral dose of PF-06865571 100 mg on Day 1
Drug: PF-06865571 100 mg
PF-06865571 in 100 mg oral tablet will be administered on Day 1




Primary Outcome Measures :
  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) [ Time Frame: Hour 0, 0.5, 1, 2, 4, 6, 8, 10, 12, and 16 on Day 1, Hour 24 and 36 on Day 2, Hour 48 on Day 3 and Hour 72 on Day 4 ]
  2. Area under the plasma concentration-time AUC([last)] [ Time Frame: Hour 0, 0.5, 1, 2, 4, 6, 7, 8, 10, 12, 14, and 16 on Day 1, Hour 24 and 36 on Day 2, Hour 48 on Day 3 and Hour 72 on Day 4 ]
  3. Maximum plasma concentration [C(max)] [ Time Frame: Hour 0, 0.5, 1, 2, 4, 6, 8, 10, 12, and 16 on Day 1, Hour 24 and 36 on Day 2, Hour 48 on Day 3 and Hour 72 on Day 4 ]

Secondary Outcome Measures :
  1. Number of Subjects Reporting Treatment-emergent AEs [ Time Frame: Baseline to Day 30 ]
  2. Number of Subjects with Clinically Significant Change from Baseline in Laboratory tests [ Time Frame: Baseline to Day 4 ]
  3. Number of Subjects with Clinically Significant Change from Baseline in Vital Signs [ Time Frame: Baseline to Day 4 ]
  4. Number of Subjects with Clinically Significant Change from Baseline in 12-lead ECGs [ Time Frame: Baseline to Day 4 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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, inclusive; and a total body weight >50 kg (110 lb), at the Screening visit; with a single repeat assessment of total body weight (and hence BMI), on a separate day permitted to assess eligibility, if needed.
  • Capable of giving signed informed consent.

Exclusion Criteria

  • Any condition possibly affecting drug absorption (eg, prior bariatric surgery,gastrectomy, ileal resection).
  • 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 behavior 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.
  • 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-06865571.
  • A positive urine drug test, for illicit drugs on Day -1,
  • At Screening or Day -1, a positive breath alcohol test.
  • 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.
  • Unwilling or unable to comply with the criteria in the Lifestyle Considerations.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091061


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04091061     History of Changes
Other Study ID Numbers: C2541009
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Non-alcoholic Fatty Liver Disease
Non-alcoholic steatohepatitis
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases