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

NCT03161015 | Completed Phase 1 FDA Drug

• 1 other identifier: GBT440-0110
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (4)

• 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

• 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 Outcomes (1)

• Number of subjects with treatment-related Adverse events

  28 days max

Study Arms (4)

GBT440 Dose 1: Severe Renal Impairment

EXPERIMENTAL

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

Drug: GBT440

GBT440 Dose 1: Moderate Renal Impairment

EXPERIMENTAL

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

Drug: GBT440

GBT440 Dose 1: Mild Renal Impairment

EXPERIMENTAL

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

Drug: GBT440

GBT440 Dose 1: Normal Renal function

EXPERIMENTAL

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

Drug: GBT440

Interventions

GBT440 DRUG

Oral

GBT440 Dose 1: Mild Renal Impairment; GBT440 Dose 1: Moderate Renal Impairment; GBT440 Dose 1: Normal Renal function; GBT440 Dose 1: Severe Renal Impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Global Blood Therapeutics: lead

Study Sites (2)

University of Miami

Miami, Florida, 33136, United States

Location

OCRC

Orlando, Florida, 32809, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

voxelotor

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Carla Washington

  Global Blood Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multiple-center, nonrandomized, open-label, parallel group study

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 19, 2017
• Study Start: November 1, 2016
• Primary Completion: May 25, 2017
• Study Completion: July 6, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

US (2)