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

A Phase 1, Open-Label Study to Characterize the Pharmacokinetics and Safety of a Single Oral Dose of GBT440 in Subjects With Hepatic Impairment

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: GBT440

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
    • Orlando, Florida, United States, 32809
      • OCRC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GBT440 Dose 1:Mild hepatic impairment; Child Pugh A	Drug: GBT440; Oral
Experimental: GBT440 Dose 1:Moderate hep. impairment; Child Pugh B	Drug: GBT440; Oral
Experimental: GBT440 Dose 1:Severe hepatic impairment; Child Pugh C	Drug: GBT440; Oral
Experimental: GBT440 Dose 1:Normal hepatic function; Healthy subjects	Drug: GBT440; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the Cmax of GBT440 in patients with mild, moderate, or severe hepatic impairment	Maximum observed plasma concentration	28 days max
To assess the Tmax of GBT440 in patients with mild, moderate, or severe hepatic impairment	Time at which maximum concentration was observed	28 days max
To assess the AUC of GBT440 in patients with mild, moderate, or severe hepatic impairment	Area under the concentration-time curve	28 days max
To assess the T1/2 of GBT440 in patients with mild, moderate, or severe hepatic impairment	Terminal elimination half-life	28 days max

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	28 days max
Clinical laboratory tests	28 days max
Physical examination findings	28 days max
Vital signs	28 days max
Electrocardiograms	28 days max

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2017
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): March 22, 2018

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: GBT440-0112; C5341047 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No