Phase I Study on Multiple Oral Dosing of CG100649

NCT01154790 | Completed Phase 1

• 1 other identifier: CG100649-1-04
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Safety (normal results for safety tests)

  Cardiovascular: BP,ECG, Holter monitoring GI: Fecal occult blood Kidney: Urine electrolyte test Adverse events Physical examination, vital signs

  27days

Study Arms (3)

CG100649

EXPERIMENTAL

By the amount of doses, the groups are classified

Drug: CG100649; Drug: Placebo

Naproxen

ACTIVE COMPARATOR

By the amount of doses, the groups are classified

Drug: Placebo; Drug: Naproxen

Placebo

PLACEBO COMPARATOR

By the amount of doses, the groups are classified

Drug: Placebo

Interventions

CG100649 DRUG

6 subjects: study drug 2 subjects: placebo

CG100649

Placebo DRUG

6 subjects: study drug 2 subjects: placebo

CG100649; Naproxen; Placebo

Naproxen DRUG

6 subjects: study drug 2 subjects: placebo

Also known as: NAXEN

Naproxen

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• CrystalGenomics, Inc.: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

CG100649; Naproxen

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Seonggu Ro

  CrystalGenomics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: July 1, 2010
• Study Start: June 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 28, 2016

Record last verified: 2010-06

Locations

KR (1)