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

NCT03114540 | Completed Phase 1 FDA Drug

• 2 other identifiers: GBT440-0112C5341047
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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

Study Arms (4)

GBT440 Dose 1:Mild hepatic impairment

EXPERIMENTAL

Child Pugh A

Drug: GBT440

GBT440 Dose 1:Moderate hep. impairment

EXPERIMENTAL

Child Pugh B

Drug: GBT440

GBT440 Dose 1:Severe hepatic impairment

EXPERIMENTAL

Child Pugh C

Drug: GBT440

GBT440 Dose 1:Normal hepatic function

EXPERIMENTAL

Healthy subjects

Drug: GBT440

Interventions

GBT440 DRUG

Oral

GBT440 Dose 1:Mild hepatic impairment; GBT440 Dose 1:Moderate hep. impairment; GBT440 Dose 1:Normal hepatic function; GBT440 Dose 1:Severe hepatic impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

University of Miami

Miami, Florida, 33136, United States

Location

OCRC

Orlando, Florida, 32809, United States

Location

Related Links

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

MeSH Terms

Interventions

voxelotor

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multiple-center, nonrandomized, open-label, parallel group study

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 14, 2017
• Study Start: March 17, 2017
• Primary Completion: February 28, 2018
• Study Completion: March 22, 2018
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

US (2)