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Completed

NCT Number: NCT01848470

Multiple Ascending Doses Study of CG400549

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PRA International clinical center

Zuidlaren, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

CG400549 640mg

Drug

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

CG400549 320 mg

Drug

multiple oral doses of 320 mg CG400549 (n=6) QD for 5 days in the fed state

CG400549 640 mg

Drug

multiple oral doses of 640 mg CG400549 (n=6) QD for 5 days in the fed state

CG400549 960 mg

Drug

multiple oral doses of 960 mg CG400549 (n=6) QD for 5 days in the fed state

Placebo 640mg

Drug

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

Placebo 320mg

Drug

multiple oral doses of 320 mg placebo (n=2) QD for 5 days in the fed state

placebo 960 mg

Drug

multiple oral doses of 960 mg placebo (n=2) QD for 5 days in the fed state

Primary outcomes

  1. Number of participants with adverse events

    Time frame: From Time the ICF is signed until Follow up Visit (15 days after study drug administration)

Secondary outcomes

  1. Pharmacokinetics-tmax(h), Cmax (ng/mL), Auc (0-24), T1/2(h)

    Time frame: Day1 and Day5

    To determine the pharmacokinetics of CG400549 following oral administration of multiple ascending doses of CG400549 in healthy male subjects.

Sponsors and collaborators

Lead sponsor

CrystalGenomics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 7, 2013
Registry last updated
May 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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