Study to Compare Safety and Pharmacokinetics of "CG1801" and "CGL1802" in Healthy Volunteers

NCT03774355 | Completed Phase 1 DMC

• 1 other identifier: CG100649-1-07
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this open-label, randomized, 2\*2 crossover study is to compare the safety and Pharmacokinetics CG1801 and CGL1802 in Healthy Volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under Curve [AUC]last of polmacoxib AUClast of polmacoxib AUClast of polmacoxib AUClast of polmacoxib

  Area Under Curve \[AUC\]last of CGL1802 will be evaluated

  Day1 pre-dose and each of the post-doses of each of the 2 treatment periods in CG1801 and CGL1802 Group.

• Maximum Plasma Concentration [Cmax] of polmacoxib

  Maximum Plasma Concentration \[Cmax\] of CGL1802 will be evaluated

  Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.

Secondary Outcomes (7)

• Area Under Curve [AUC]last of polmacoxib

  Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.

• Maximum Plasma Concentration [Cmax] of polmacoxib

  Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.

• AUCinf of polmacoxib

  Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.

• Time to maximum plasma concentration [Tmax] of polmacoxib

  Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.

• t1/2 of polmacoxib

  Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.

Study Arms (2)

CG1801

EXPERIMENTAL

Dosing 'CG1801' followed by dosing 'CGL1802'

Drug: CG1801

CGL 1802

EXPERIMENTAL

Dosing 'CGL1802' followed by dosing 'CG1801'

Drug: CGL1802

Interventions

CG1801 DRUG

Administration CG1801 2mg single dose in phase 1 and Administration CGL1802 2mg single dose phase 2.

CG1801

CGL1802 DRUG

Administration CGL1802 2mg single dose in phase 1 and Administration CG1801 2mg single dose phase 2

CGL 1802

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female aged ≥ 19 years and ≤ 50 years
• Without inborn or chronic disease and no symptoms in physical examination
• BMI(Body Mass Index) result ≥ 18kg/m 2 and ≤ 30kg/m2
• Adequate clinical laboratory test results as evidenced by Hematology, Hemostasis, Biochemistry, Urinalysis, Serology and so on
• After taking a rest in sitting position for 5 minutes, subjects who have blood pressure (90 mmHg ≤ Systolic BP ≤ 139 mmHg, and 60 mmHg ≤ Diastolic BP ≤ 89 mmHg)
• Subject who understand the objective, method of the study and the characteristics of investigational drug and expected adverse events and provide written informed consent prior to study participation
• Negative pregnancy test(hCG) and agree to contraception during the trial

You may not qualify if:

• History of hypersensitivity to investigational products
• History of hypersensitivity or allergic reaction to sulfonamide.
• Patients with a history of asthma, acute rhinitis, nonspecific polyps, angioedema, urticaria or allergic reactions to aspirin or other nonsteroidal anti- inflammatory analgesics (including COX-2 inhibitors)
• Uncontrolled hypertension (over the Systolic BP 140 mm Hg or Diastolic BP 90 mmHG)
• Edema or Fluid retention
• AST / ALT \> 1.5 times the normal range including additional and Screening blood tests before randomization.
• MDRD \< 60mL / min / 1.73m2 including additional and Screening blood tests before randomization.
• Patient with an active peptic ulcer or gastrointestinal bleeding
• Patient with inflammatory intestinal disease such as Crohn's disease or ulcerative colitis
• Patient with Congestive Heart Failure (NYHA II - IV)
• Established ischemic heart disease patients, peripheral arterial diseases, and/or brain vascular diseases patient
• Patient performed CABG within 30 days prior to the first administration of the investigational drug
• Patient has hyperkalemia
• Patient has blood coagulation disorder or administration the anticoagulant
• Patient with gastrointestinal related disease or gastrotomy history (except appendicitis or hernia surgery) that may affect the absorption of the investigational drug.

Sponsors & Collaborators

• CrystalGenomics, Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Study Officials

• Kyung-Sang Yu, Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2018
• First Posted: December 12, 2018
• Study Start: December 17, 2018
• Primary Completion: May 3, 2019
• Study Completion: May 3, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

KR (1)