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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-07-06

Brief Summary

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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.

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Detailed Description

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

Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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GBT440 Dose 1: Severe Renal Impairment

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

Group Type EXPERIMENTAL

GBT440

Intervention Type DRUG

Oral

GBT440 Dose 1: Moderate Renal Impairment

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

Group Type EXPERIMENTAL

GBT440

Intervention Type DRUG

Oral

GBT440 Dose 1: Mild Renal Impairment

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

Group Type EXPERIMENTAL

GBT440

Intervention Type DRUG

Oral

GBT440 Dose 1: Normal Renal function

eGFR \> or = 90 mL/min/1.73m2

Group Type EXPERIMENTAL

GBT440

Intervention Type DRUG

Oral

Interventions

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GBT440

Oral

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes