Single-Dose PK Study of GBT440 in Subjects With Renal Impairment

Renal Impairment Clinical Trial

Official title:

A Non-Randomized, Open-Label, Parallel Group, Single-Dose Study to Compare the Pharmacokinetics of GBT440 in Subjects With Renal Impaired Function to Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03161015
• Other study ID #: GBT440-0110
• Status: Completed
• Phase: Phase 1
• First received: May 8, 2017
• Last updated: February 20, 2018
• Start date: November 2016
• Est. completion date: July 6, 2017

Study information

• Verified date: February 2018
• Source: Global Blood Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild, moderate, or severe renal impairment disease and healthy subjects with normal renal function.

Description:

Up to 40 adult subjects will be enrolled. Safety and PK assessments will be performed at selected time points throughout the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 6, 2017
• Est. primary completion date: May 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

All subjects:

• Males or females, 18 to 80 years old

• Willing and able to give written informed consent

Subjects with renal impairment:

• Severe renal impairment (eGFR < 30 mL/min/1.73m2, not on dialysis)

• Moderate renal impairment (30 mL/min/1.73m2 = or < eGFR < 60 mL/min/1.73m2)

• Mild renal impairment (60 mL/min/1.73m2 = or < eGFR < 90 mL/min/1.73m2)

Healthy subjects:

• Match in age, gender and body mass index with renal 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

Subjects with renal impairment:

• History of clinically significant hepatic disease e.g. hepatitis, cirrhosis and or liver enzymes (ALT, AST, GGT and total bilirubin) > 5 times the upper limit of normal within the past year

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• GBT440
Oral

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida
United States	OCRC	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Global Blood Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function	Maximum observed plasma concentration	28 days max
Primary	Tmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function		28 days max
Primary	AUC of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function		28 days max
Primary	T1/2 of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function		28 days max
Secondary	Number of subjects with treatment-related Adverse events		28 days max