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CG400549 Single Ascending Dose Study

NCT01085578 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-05-20

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

CG400549/placebo

Period 1: a single oral dose of 80 mg CG400549 or placebo on Day 1 Period 2: a single oral dose of 320 mg CG400549 or placebo on Day 1 Period 3: a single oral dose of 1280 mg CG400549 or placebo on Day 1

DRUG

CG400549/placebo

Period 1: a single oral dose of 160 mg CG400549 or placebo on Day 1 Period 2: a single oral dose of 640 mg CG400549 or placebo on Day 1 Period 3: a single oral dose of 1920 mg CG400549 or placebo on Day 1

DRUG

CG400549

Period 1: a single oral dose of 640 mg CG400549 on Day 1 in the fasted state Period 2: a single oral dose of 640 mg CG400549 on Day 1 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
2009-10-31
Primary Completion
2009-12-31
Completion
2009-12-31

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 NCT01085578 on ClinicalTrials.gov