A Study of the Safety, Blood Levels and Biological Effects of GBT440 in Healthy Subjects and Subjects With Sickle Cell Disease
NCT02285088 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 133
Last updated 2018-02-15
Summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic effects of GBT440 compared with placebo in healthy subjects and subjects with sickle cell disease (SCD).
Conditions
- Healthy Subjects
- Sickle Cell Disease
Interventions
- DRUG
-
GBT440
GBT440 will be administered as oral capsules
- DRUG
-
Matching placebo will be administered as oral capsules
Sponsors & Collaborators
-
Global Blood Therapeutics
lead INDUSTRY
Principal Investigators
-
Josh Lehrer-Graiwer, MD · Global Blood Therapeutics
-
Timothy Mant, FRCP FFPM · Guy's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-12-31
- Primary Completion
- 2017-03-31
- Completion
- 2017-05-31
Countries
- United Kingdom
Study Locations
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