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

Hepatic Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03114540
• Other study ID #: GBT440-0112
• Secondary ID: C5341047
• Status: Completed
• Phase: Phase 1
• Start date: March 17, 2017
• Est. completion date: March 22, 2018

Study information

• Verified date: July 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Approximately 24 to 28 subjects will be enrolled. Safety and PK assessments will be performed at selected time points throughout the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 22, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• GBT440
Oral

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida
United States	OCRC	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the Cmax of GBT440 in patients with mild, moderate, or severe hepatic impairment	Maximum observed plasma concentration	28 days max
Primary	To assess the Tmax of GBT440 in patients with mild, moderate, or severe hepatic impairment	Time at which maximum concentration was observed	28 days max
Primary	To assess the AUC of GBT440 in patients with mild, moderate, or severe hepatic impairment	Area under the concentration-time curve	28 days max
Primary	To assess the T1/2 of GBT440 in patients with mild, moderate, or severe hepatic impairment	Terminal elimination half-life	28 days max
Secondary	Adverse events		28 days max
Secondary	Clinical laboratory tests		28 days max
Secondary	Physical examination findings		28 days max
Secondary	Vital signs		28 days max
Secondary	Electrocardiograms		28 days max

External Links

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