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

Primary Purpose

Renal Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

GBT440

About this trial

This is an interventional other trial for Renal Impairment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Miami
OCRC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

GBT440 Dose 1: Severe Renal Impairment

GBT440 Dose 1: Moderate Renal Impairment

GBT440 Dose 1: Mild Renal Impairment

GBT440 Dose 1: Normal Renal function

Arm Description

eGFR < 30 mL/min/1.73m2, not on dialysis

30 mL/min/1.73m2 = or < eGFR < 60 mL/min/1.73m2

60 mL/min/1.73m2 = or < eGFR < 90 mL/min/1.73m2

eGFR > or = 90 mL/min/1.73m2

Outcomes

Primary Outcome Measures

Cmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function

Maximum observed plasma concentration

Tmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function

AUC of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function

T1/2 of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function

Secondary Outcome Measures

Number of subjects with treatment-related Adverse events

Full Information

NCT ID

NCT03161015

First Posted

May 8, 2017

Last Updated

February 20, 2018

Sponsor

Global Blood Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT03161015

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

November 2016 (Actual)

Primary Completion Date

May 25, 2017 (Actual)

Study Completion Date

July 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Global Blood Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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, moderate, or severe renal impairment disease and healthy subjects with normal renal function.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Impairment

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GBT440 Dose 1: Severe Renal Impairment

Arm Type

Experimental

Arm Description

eGFR < 30 mL/min/1.73m2, not on dialysis

Arm Title

GBT440 Dose 1: Moderate Renal Impairment

Arm Type

Experimental

Arm Description

30 mL/min/1.73m2 = or < eGFR < 60 mL/min/1.73m2

Arm Title

GBT440 Dose 1: Mild Renal Impairment

Arm Type

Experimental

Arm Description

60 mL/min/1.73m2 = or < eGFR < 90 mL/min/1.73m2

Arm Title

GBT440 Dose 1: Normal Renal function

Arm Type

Experimental

Arm Description

eGFR > or = 90 mL/min/1.73m2

Intervention Type

Drug

Intervention Name(s)

GBT440

Intervention Description

Oral

Primary Outcome Measure Information:

Title

Cmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function

Description

Maximum observed plasma concentration

Time Frame

28 days max

Title

Tmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function

Time Frame

28 days max

Title

AUC of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function

Time Frame

28 days max

Title

T1/2 of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function

Time Frame

28 days max

Secondary Outcome Measure Information:

Title

Number of subjects with treatment-related Adverse events

Time Frame

28 days max

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carla Washington

Organizational Affiliation

Global Blood Therapeutics

Official's Role

Study Director

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

OCRC

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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