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

CompletedPhase 1

Sponsor: Pfizer

Conditions: Hepatic Impairment

Interventions: GBT440

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (2)

Miami, Florida, United States
Orlando, Florida, United States