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Single-Dose PK and Safety Study of GBT440 in Subjects With Hepatic Impairment

Primary Purpose

Hepatic Impairment

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GBT440
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatic Impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All subjects:

  • Males or females, 18 to 75 years old
  • Willing and able to give written informed consent

Patients with hepatic impairment:

  • Mild hepatic impairment (Child-Pugh A [5-6 points])
  • Moderate hepatic impairment (Child-Pugh B [7-9 points])
  • Severe hepatic impairment (Child-Pugh C [10-15 points])

Healthy subjects:

  • Match in age, gender and body mass index with hepatic impaired subjects
  • Healthy and without clinically significant abnormalities in vital signs, ECGs, physical exam, clinical laboratory evaluations, medical and surgical history

Exclusion Criteria:

All subjects:

  • Participation in another clinical trial of an investigational drug (or medical device) within 30 days of the last dose of investigational drug or 5 half-lives whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device)
  • Any signs or symptoms of acute illness at screening or Day -1
  • History or presence of clinically significant allergic, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease

Patients with hepatic impairment:

  • History of liver transplantation, hepatic mass suggestive of hepatocellular carcinoma or acute liver disease
  • Screening serum ALT or AST >5 times the upper limit of normal

Sites / Locations

  • University of Miami
  • OCRC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

GBT440 Dose 1:Mild hepatic impairment

GBT440 Dose 1:Moderate hep. impairment

GBT440 Dose 1:Severe hepatic impairment

GBT440 Dose 1:Normal hepatic function

Arm Description

Child Pugh A

Child Pugh B

Child Pugh C

Healthy subjects

Outcomes

Primary Outcome Measures

To assess the Cmax of GBT440 in patients with mild, moderate, or severe hepatic impairment
Maximum observed plasma concentration
To assess the Tmax of GBT440 in patients with mild, moderate, or severe hepatic impairment
Time at which maximum concentration was observed
To assess the AUC of GBT440 in patients with mild, moderate, or severe hepatic impairment
Area under the concentration-time curve
To assess the T1/2 of GBT440 in patients with mild, moderate, or severe hepatic impairment
Terminal elimination half-life

Secondary Outcome Measures

Adverse events
Clinical laboratory tests
Physical examination findings
Vital signs
Electrocardiograms

Full Information

First Posted
March 28, 2017
Last Updated
July 14, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03114540
Brief Title
Single-Dose PK and Safety Study of GBT440 in Subjects With Hepatic Impairment
Official Title
A Phase 1, Open-Label Study to Characterize the Pharmacokinetics and Safety of a Single Oral Dose of GBT440 in Subjects With Hepatic Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 17, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
March 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild (Child-Pugh A), moderate (Child-Pugh B), or severe (Child-Pugh C) hepatic impairment disease and healthy subjects with normal hepatic function.
Detailed Description
Approximately 24 to 28 subjects will be enrolled. Safety and PK assessments will be performed at selected time points throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Multiple-center, nonrandomized, open-label, parallel group study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GBT440 Dose 1:Mild hepatic impairment
Arm Type
Experimental
Arm Description
Child Pugh A
Arm Title
GBT440 Dose 1:Moderate hep. impairment
Arm Type
Experimental
Arm Description
Child Pugh B
Arm Title
GBT440 Dose 1:Severe hepatic impairment
Arm Type
Experimental
Arm Description
Child Pugh C
Arm Title
GBT440 Dose 1:Normal hepatic function
Arm Type
Experimental
Arm Description
Healthy subjects
Intervention Type
Drug
Intervention Name(s)
GBT440
Intervention Description
Oral
Primary Outcome Measure Information:
Title
To assess the Cmax of GBT440 in patients with mild, moderate, or severe hepatic impairment
Description
Maximum observed plasma concentration
Time Frame
28 days max
Title
To assess the Tmax of GBT440 in patients with mild, moderate, or severe hepatic impairment
Description
Time at which maximum concentration was observed
Time Frame
28 days max
Title
To assess the AUC of GBT440 in patients with mild, moderate, or severe hepatic impairment
Description
Area under the concentration-time curve
Time Frame
28 days max
Title
To assess the T1/2 of GBT440 in patients with mild, moderate, or severe hepatic impairment
Description
Terminal elimination half-life
Time Frame
28 days max
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
28 days max
Title
Clinical laboratory tests
Time Frame
28 days max
Title
Physical examination findings
Time Frame
28 days max
Title
Vital signs
Time Frame
28 days max
Title
Electrocardiograms
Time Frame
28 days max

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All subjects: Males or females, 18 to 75 years old Willing and able to give written informed consent Patients with hepatic impairment: Mild hepatic impairment (Child-Pugh A [5-6 points]) Moderate hepatic impairment (Child-Pugh B [7-9 points]) Severe hepatic impairment (Child-Pugh C [10-15 points]) Healthy subjects: Match in age, gender and body mass index with hepatic impaired subjects Healthy and without clinically significant abnormalities in vital signs, ECGs, physical exam, clinical laboratory evaluations, medical and surgical history Exclusion Criteria: All subjects: Participation in another clinical trial of an investigational drug (or medical device) within 30 days of the last dose of investigational drug or 5 half-lives whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device) Any signs or symptoms of acute illness at screening or Day -1 History or presence of clinically significant allergic, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease Patients with hepatic impairment: History of liver transplantation, hepatic mass suggestive of hepatocellular carcinoma or acute liver disease Screening serum ALT or AST >5 times the upper limit of normal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
OCRC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=GBT440-0112
Description
To obtain contact information for a study center near you, click here.

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Single-Dose PK and Safety Study of GBT440 in Subjects With Hepatic Impairment

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