Single-Dose PK Study of GBT440 in Subjects With Renal Impairment
Completed · Phase 1
Conditions studied: Renal Impairment
In brief
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.
Key facts
- Study ID
- NCT03161015
- Run by
- Global Blood Therapeutics
- People needed
- 16
- Starts
- 2016-11-01
- Expected to finish
- 2017-07-06
- Last updated by the study team
- 2018-02-22
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- University of Miami — Miami, Florida, United States
- OCRC — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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