Status:
COMPLETED
Multiple Ascending Doses Study of CG400549
Lead Sponsor:
CrystalGenomics, Inc.
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- Age:18-55 years, inclusive
- Body Mass Index :19-30 kg/m2, inclusive
- Sex:male
- Other criteria:healthy; non-smoking or smoking ≤ 10 cigarettes/day
Exclusion
- Evidence of clinically relevant pathology
- History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month of study
- Presence or history of esophageal or gastroduodenal ulceration within 1 month before screening.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01848470
Start Date
May 1 2010
End Date
March 1 2011
Last Update
May 7 2013
Active Locations (1)
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1
PRA International clinical center
Zuidlaren, Netherlands