NCT02567682

Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects

A Phase 1, Open-Label Study to Evaluate the Effect of Multiple Doses of GBT440 on the Pharmacokinetics of Probe Substrates for CYP1A2, CYP2C9, CYP2C19, and CYP3A4 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Global Blood Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	GBT440	GBT440 capsules followed by Caffeine, S-warfarin+vitamin K, Omeprazole, and Midazolam

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-10-05
• Last updated: 2017-04-12

Locations

1 site across 1 country: United States