NCT02235727

Safety and Tolerability of GBR 900 in a Single Ascending Dose Study in Healthy Subjects

A Phase 1, Double-Blind, Randomised, Placebo-Controlled, Study to Evaluate the Safety and Pharmacokinetics of GBR 900 in Adult Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Glenmark Pharmaceuticals Ltd. India · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Single Dose Study of GBR 900 in Healthy Volunteers.

Detailed description

This is a phase I study of GBR 900 in healthy volunteers. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Each participant will remain in the study for approximately 3.5 months. This study is for research purposes only and is not intended to treat any medical condition.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GBR 900
DRUG	Placebo

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2014-09-10
• Last updated: 2017-01-24

Locations

1 site across 1 country: United Kingdom