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

• Status: Completed
• Trial end date: 2017-07-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Global Blood Therapeutics

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