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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: GBT440

Study type: Interventional

Funder types: Industry

Identifiers

NCT03114540

GBT440-0112

C5341047 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 29 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 4 patient groups

GBT440 Dose 1:Mild hepatic impairment

Experimental group

Description:

Child Pugh A

Treatment:

Drug: GBT440

GBT440 Dose 1:Moderate hep. impairment

Experimental group

Description:

Child Pugh B

Treatment:

Drug: GBT440

GBT440 Dose 1:Severe hepatic impairment

Experimental group

Description:

Child Pugh C

Treatment:

Drug: GBT440

GBT440 Dose 1:Normal hepatic function

Experimental group

Description:

Healthy subjects

Treatment:

Drug: GBT440