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

• Status: Completed
• Trial end date: 2018-03-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Global Blood Therapeutics

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