NCT01154790

Phase I Study on Multiple Oral Dosing of CG100649

A Randomized, Double-blind Study Evaluating the Upper Gastrointestinal Safety on Multiple Doses of CG100649 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: CrystalGenomics, Inc. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of 3 escalating loading and maintenance dose regimens of CG100649 administered orally for 7 total days in healthy volunteers.

Detailed description

Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used CTCAE and normal ranges if relevant.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CG100649	6 subjects: study drug 2 subjects: placebo
DRUG	Placebo	6 subjects: study drug 2 subjects: placebo
DRUG	Naproxen	6 subjects: study drug 2 subjects: placebo

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-07-01
• Last updated: 2016-01-28

Locations

1 site across 1 country: South Korea