NCT02497924

A Study of the Absorption, Metabolism, and Excretion of GBT440 in Healthy Male Subjects

A Phase 1 Study to Investigate Absorption, Metabolism, and Excretion After Establishment of Steady State Via GBT440 Loading and Maintenance Dosing Followed by a Single Oral Dose Administration of [14C]-GBT440 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Global Blood Therapeutics · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Anemia, Sickle Cell

Interventions

Type	Name	Description
DRUG	GBT440	GBT440 capsules followed by single dose of \[C14\] GBT440 oral suspension

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-07-15
• Last updated: 2017-04-12

Locations

1 site across 1 country: United States