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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-17

Study Completion Date

2018-03-22

Brief Summary

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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.

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Detailed Description

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

Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Multiple-center, nonrandomized, open-label, parallel group study

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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GBT440 Dose 1:Mild hepatic impairment

Child Pugh A

Group Type EXPERIMENTAL

GBT440

Intervention Type DRUG

Oral

GBT440 Dose 1:Moderate hep. impairment

Child Pugh B

Group Type EXPERIMENTAL

GBT440

Intervention Type DRUG

Oral

GBT440 Dose 1:Severe hepatic impairment

Child Pugh C

Group Type EXPERIMENTAL

GBT440

Intervention Type DRUG

Oral

GBT440 Dose 1:Normal hepatic function

Healthy subjects

Group Type EXPERIMENTAL

GBT440

Intervention Type DRUG

Oral

Interventions

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GBT440

Oral

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes