Phase I Study on Multiple Oral Dosing of CG100649

NCT ID: NCT01154790

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CG100649

By the amount of doses, the groups are classified

Group Type: EXPERIMENTAL

CG100649

Intervention Type: DRUG

6 subjects: study drug 2 subjects: placebo

Placebo

Intervention Type: DRUG

6 subjects: study drug 2 subjects: placebo

Naproxen

By the amount of doses, the groups are classified

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

6 subjects: study drug 2 subjects: placebo

Naproxen

Intervention Type: DRUG

6 subjects: study drug 2 subjects: placebo

Placebo

By the amount of doses, the groups are classified

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

6 subjects: study drug 2 subjects: placebo

Interventions

CG100649

6 subjects: study drug 2 subjects: placebo

Intervention Type: DRUG

Placebo

6 subjects: study drug 2 subjects: placebo

Intervention Type: DRUG

Naproxen

6 subjects: study drug 2 subjects: placebo

Intervention Type: DRUG

Other Intervention Names

NAXEN

Eligibility Criteria

Inclusion Criteria

1. 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.

2. No significant congenital/chronic disease. No symptoms in physical examination.

3. Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.

4. 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

1. History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.

2. History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.

3. History of known hypersensitivity to drugs including CG100649.

4. 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).

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CrystalGenomics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seonggu Ro

Role: STUDY_DIRECTOR

CrystalGenomics, Inc.

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CG100649-1-04

Identifier Type: -

Identifier Source: org_study_id