Clinical trial NCT03114540: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-04-14
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multiple-center, nonrandomized, open-label, parallel group study
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: To assess the Cmax of GBT440 in patients with mild, moderate, or severe hepatic impairment
timeFrame: 28 days max
measure: To assess the Tmax of GBT440 in patients with mild, moderate, or severe hepatic impairment
timeFrame: 28 days max
measure: To assess the AUC of GBT440 in patients with mild, moderate, or severe hepatic impairment
timeFrame: 28 days max
measure: To assess the T1/2 of GBT440 in patients with mild, moderate, or severe hepatic impairment
timeFrame: 28 days max
Secondary outcomes:
measure: Adverse events
timeFrame: 28 days max
measure: Clinical laboratory tests
timeFrame: 28 days max
measure: Physical examination findings
timeFrame: 28 days max
measure: Vital signs
timeFrame: 28 days max
measure: Electrocardiograms
timeFrame: 28 days max
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: OCRC
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: