Drug-Drug Interaction Study of "CG-651" in Healthy Volunteer

NCT05370716 | Completed Phase 1

• 1 other identifier: CG100651-1-01
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This is randomized , open-label, multiple-dose, parallel study to compare the pharmacokinetics and to evaluate Drug-Drug Interaction of "CG-651" in healthy volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Cmax of polmacoxib and pregabalin

  Maximum Observed Plasma Concentration

  upto 4 weeks

• AUC of polmacoxib and pregabalin

  Area Under the Concentration-Time Curve

  upto 4 weeks

• The Number of Participants Who Experienced Adverse events (AEs)

  A non-serious adverse event is any untoward medical occurrence. A serious adverse event is any adverse event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; requires intervention to prevent permanent impairment or damage.

  upto 4 weeks

Study Arms (3)

Group A

EXPERIMENTAL

Pregabalin + Polmacoxib

Drug: Polmacoxib; Drug: Pregabalin

Group B

ACTIVE COMPARATOR

Polmacoxib

Drug: Polmacoxib

Group C

ACTIVE COMPARATOR

Pregabalin

Drug: Pregabalin

Interventions

Polmacoxib DRUG

Polmacoxib

Group A; Group B

Pregabalin DRUG

Pregabalin

Group A; Group C

Eligibility Criteria

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

You may qualify if:

• Adequate Biochemistry, Urinalysis, Serology and so on.
• 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, non specific polyps, angioedema, urticaria or allergic reactions to aspirin or other nonsteroidal anti-inflammatory analgesics(including COX-2 inhibitors)
• Any other reason or situations that the investigator decides the patient is not eligible to participate the clinical trial.

Sponsors & Collaborators

• CrystalGenomics, Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

CG100649; Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (open label)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: * Group A: Pregabalin + Polmacoxib * Group B: Polmacoxib * Group C: Pregabalin

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: May 11, 2022
• Study Start: November 11, 2019
• Primary Completion: April 30, 2020
• Study Completion: May 19, 2020
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

KR (1)