NCT02567695

A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects

A Phase 1, Single-Dose, Open-Label, Randomized, Two-Period Crossover Study to Evaluate the Relative Bioavailability of GBT440 300 mg Administered as Capsule Formulations in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Global Blood Therapeutics · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	GBT440	Test: GBT440 300 mg capsule (high-strength) Reference: GBT440 100 mg capsule (low-strength)

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-10-05
• Last updated: 2017-04-12

Locations

1 site across 1 country: United States