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Multiple Ascending Doses Study of CG400549

NCT01848470 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2013-05-07

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • CrystalGenomics, Inc.

    lead INDUSTRY

Principal Investigators

  • Seonggu Ro, PhD · CrystalGenomics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01848470 on ClinicalTrials.gov