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Last Updated: May 11, 2021

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CLINICAL TRIALS PROFILE FOR GBT440

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Clinical Trials for GBT440

Trial ID Title Status Sponsor Phase Summary
NCT02285088 A Study of the Safety, Blood Levels and Biological Effects of GBT440 in Healthy Subjects and Subjects With Sickle Cell Disease Recruiting Global Blood Therapeutics Phase 1 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).
NCT02497924 A Study of the Absorption, Metabolism, and Excretion of GBT440 in Healthy Male Subjects Active, not recruiting Global Blood Therapeutics Phase 1 This study will provide information regarding the metabolic pathway of GBT440, the need for evaluation of potential drug-drug interactions, and the need for studies in special populations. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of GBT440, providing further quantitative information on the disposition of GBT440. The results from this study will permit a comprehensive comparison between animal and human routes of elimination and metabolic profiles of GBT440.
NCT02567682 Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects Recruiting Global Blood Therapeutics Phase 1 The purpose of this study to evaluate the effect of concomitant administration of GBT440 on caffeine (a CYP1A2 probe substrate), S warfarin (a CYP2C9 probe substrate), omeprazole (a CYP2C19 probe substrate), and midazolam (a CYP3A4 probe substrate) plasma concentrations.
NCT02567695 A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects Recruiting Global Blood Therapeutics Phase 1 The purpose of this study is to evaluate the relative bioavailability of a single 300 mg dose of GBT440 administered as a high strength (1 × 300 mg) capsule versus a low strength (3 × 100 mg) capsule formulation in healthy fasted subjects.
NCT02846324 Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF Recruiting Global Blood Therapeutics Phase 2 This study is a randomized, double-blind, placebo-controlled trial in which eligible IPF subjects will be randomized to receive GBT440 or Placebo orally daily.
NCT02850406 Study to Evaluate the Effect of GBT440 in Adolescents With Sickle Cell Disease Recruiting Global Blood Therapeutics Phase 2 This study consists of two parts, Part A and Part B. Part A is a single dose PK study in adolescent subjects with Sickle Cell Disease. Part B is a multiple dose safety, exploratory efficacy and PK study in adolescent Sickle Cell Disease subjects.
NCT02989168 Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at Rest Terminated Global Blood Therapeutics Phase 2 This is an open label study in which eligible IPF subjects who are using supplemental oxygen at rest will receive GBT440 orally daily.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for GBT440

Condition Name

Condition Name for
Intervention Trials
Sickle Cell Disease 11
Sickle Cell Anemia 2
Idiopathic Pulmonary Fibrosis 2
Hepatic Impairment 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Anemia, Sickle Cell 13
Pulmonary Fibrosis 2
Idiopathic Pulmonary Fibrosis 2
Idiopathic Interstitial Pneumonias 2
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Clinical Trial Locations for GBT440

Trials by Country

Trials by Country for
Location Trials
United States 37
United Kingdom 4
Lebanon 1
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Trials by US State

Trials by US State for
Location Trials
Florida 3
Pennsylvania 3
Louisiana 3
Tennessee 3
New York 2
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Clinical Trial Progress for GBT440

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 4 2
Phase 3 4
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Recruiting 11
Enrolling by invitation 2
Not yet recruiting 2
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Clinical Trial Sponsors for GBT440

Sponsor Name

Sponsor Name for
Sponsor Trials
Global Blood Therapeutics 17
Elizabeth Yang 1
University of California, San Francisco 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 17
Other 4
NIH 1
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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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Dow
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