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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

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

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

NCT ID

NCT03114540

First Posted

March 28, 2017

Last Updated

July 14, 2023

Sponsor

Pfizer

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

Data Monitoring Committee

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

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

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

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