Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03114540
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Global Blood Therapeutics

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.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Drug: GBT440 Phase 1

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multiple-center, nonrandomized, open-label, parallel group study
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : March 17, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : March 22, 2018

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




Primary Outcome Measures :
  1. To assess the Cmax of GBT440 in patients with mild, moderate, or severe hepatic impairment [ Time Frame: 28 days max ]
    Maximum observed plasma concentration

  2. To assess the Tmax of GBT440 in patients with mild, moderate, or severe hepatic impairment [ Time Frame: 28 days max ]
    Time at which maximum concentration was observed

  3. To assess the AUC of GBT440 in patients with mild, moderate, or severe hepatic impairment [ Time Frame: 28 days max ]
    Area under the concentration-time curve

  4. To assess the T1/2 of GBT440 in patients with mild, moderate, or severe hepatic impairment [ Time Frame: 28 days max ]
    Terminal elimination half-life


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 28 days max ]
  2. Clinical laboratory tests [ Time Frame: 28 days max ]
  3. Physical examination findings [ Time Frame: 28 days max ]
  4. Vital signs [ Time Frame: 28 days max ]
  5. Electrocardiograms [ Time Frame: 28 days max ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114540


Locations
Layout table for location information
United States, Florida
University of Miami
Miami, Florida, United States, 33136
OCRC
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Global Blood Therapeutics
Investigators
Layout table for investigator information
Study Director: Carla Washington Global Blood Therapeutics
Layout table for additonal information
Responsible Party: Global Blood Therapeutics
ClinicalTrials.gov Identifier: NCT03114540    
Other Study ID Numbers: GBT440-0112
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Digestive System Diseases