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OpenTrials
Completed

NCT Number: NCT01154790

Phase I Study on Multiple Oral Dosing of CG100649

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of 3 escalating loading and maintenance dose regimens of CG100649 administered orally for 7 total days in healthy volunteers.

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Key information

Conditions

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

About this study

Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used CTCAE and normal ranges if relevant.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 19-55 years old. Body weight is over 50 kg (male) and over 45 kg (female). Body weights must be within 20% of ideal body weight for their height according to the ideal body weight table.
  • No significant congenital/chronic disease. No symptoms in physical examination.
  • Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
  • Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion criteria

  • History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
  • History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
  • History of known hypersensitivity to drugs including CG100649.
  • After taking a rest in sitting position for 3 minutes, subjects who have low blood pressure (Systolic BP ≤ 90 mmHg or Diastolic BP ≤ 50 mmHg) or high blood pressure (Systolic BP ≥ 150 mmHg or Diastolic BP ≥ 100 mmHg).

Treatment and study plan

CG100649

Drug

6 subjects: study drug 2 subjects: placebo

Placebo

Drug

6 subjects: study drug 2 subjects: placebo

Naproxen

Drug

6 subjects: study drug 2 subjects: placebo

Other names: NAXEN

Primary outcomes

  1. Safety (normal results for safety tests)

    Time frame: 27days

    Cardiovascular: BP,ECG, Holter monitoring

    GI: Fecal occult blood

    Kidney: Urine electrolyte test

    Adverse events

    Physical examination, vital signs

Sponsors and collaborators

Lead sponsor

CrystalGenomics, Inc.

Industry

Registry information

Official study title

A Randomized, Double-blind Study Evaluating the Upper Gastrointestinal Safety on Multiple Doses of CG100649 in Healthy Subjects

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 1, 2010
Registry last updated
Jan 28, 2016

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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