Phase I Study on Multiple Oral Dosing of CG100649

CrystalGenomics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Naproxen; Drug: CG100649; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01154790

CG100649-1-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups, including a placebo group

CG100649

Experimental group

Description:

By the amount of doses, the groups are classified

Treatment:

Drug: Placebo

Drug: CG100649

Naproxen

Active Comparator group

Description:

By the amount of doses, the groups are classified

Treatment:

Drug: Placebo

Drug: Naproxen

Placebo

Placebo Comparator group

Description:

By the amount of doses, the groups are classified

Treatment:

Drug: Placebo