NCT01848470

Multiple Ascending Doses Study of CG400549

Evaluation of Safety, Tolerability and Pharmacokinetic Characteristics of Multiple Ascending Doses of CG400549 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: CrystalGenomics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety and tolerability of 3 multiple and escalating dose regimens of CG400549 administered orally in healthy volunteers.

Detailed description

This is a Phase 1, 3 cohorts study consisting of a randomised, double-blind, and placebo-controlled design.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CG400549 640mg	multiple oral doses of 640 mg CG400549 (n=6) BID for 5 days (Days 1-5) and a final dose on Day 6 in the fed state
DRUG	CG400549 320 mg	multiple oral doses of 320 mg CG400549 (n=6) QD for 5 days in the fed state
DRUG	CG400549 640 mg	multiple oral doses of 640 mg CG400549 (n=6) QD for 5 days in the fed state
DRUG	CG400549 960 mg	multiple oral doses of 960 mg CG400549 (n=6) QD for 5 days in the fed state
DRUG	Placebo 640mg	multiple oral doses of 640 mg placebo (n=2) BID for 5 days (Days 1-5) and a final dose on Day 6 in the fed state
DRUG	Placebo 320mg	multiple oral doses of 320 mg placebo (n=2) QD for 5 days in the fed state
DRUG	placebo 960 mg	multiple oral doses of 960 mg placebo (n=2) QD for 5 days in the fed state
DRUG	Placebo 640mg	multiple oral doses of 640 mg placebo (n=2) QD for 5 days in the fed state

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2013-05-07
• Last updated: 2013-05-07

Locations

1 site across 1 country: Netherlands