NCT02285088

A Study of the Safety, Blood Levels and Biological Effects of GBT440 in Healthy Subjects and Subjects With Sickle Cell Disease

A Phase I Randomised, Placebo-controlled, Double-blind, Single and Multiple Ascending Dose Study of the Tolerability and Pharmacokinetics of GBT440 in Healthy Subjects and Patients With Sickle Cell Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Global Blood Therapeutics · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	GBT440	GBT440 will be administered as oral capsules
DRUG	Placebo	Matching placebo will be administered as oral capsules

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-03-01
• Completion: 2017-05-01
• First posted: 2014-11-06
• Last updated: 2018-02-15

Locations

1 site across 1 country: United Kingdom