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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03161015

Enrollment

Registered

2017-05-19

Start date

2016-11-30

Completion date

2017-07-06

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Impairment

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.

Interventions

DRUGGBT440

Oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Cmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function	28 days max	Maximum observed plasma concentration
Tmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function	28 days max	—
AUC of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function	28 days max	—
T1/2 of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function	28 days max	—

Secondary

Measure	Time frame
Number of subjects with treatment-related Adverse events	28 days max

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026