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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Polmacoxib; Drug: Pregabalin

• Registration Number: NCT05370716
• Lead Sponsor: CrystalGenomics, Inc.

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.

Detailed Description

Total of 39 health volunteers will be randomized to receive either of Group A,B or C. (13 subjects each)

\[Group A\] Pregabalin+ Polmacoxib. \[Group B\] Polmacoxib \[Group C\] Pregabalin

Study Timeline

• Study Start: 2019-11-11
• Study First Submitted: 2019-12-03
• Primary Completion: 2020-04-30
• Study Completion: 2020-05-19
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-08
• Study First Posted: 2022-05-11
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• 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.

Key

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Polmacoxib	Pregabalin + Polmacoxib
Group A	Pregabalin	Pregabalin + Polmacoxib
Group B	Polmacoxib	Polmacoxib
Group C	Pregabalin	Pregabalin

Primary Outcome Measures

Name	Time	Method
Cmax of polmacoxib and pregabalin	upto 4 weeks	Maximum Observed Plasma Concentration
AUC of polmacoxib and pregabalin	upto 4 weeks	Area Under the Concentration-Time Curve
The Number of Participants Who Experienced Adverse events (AEs)	upto 4 weeks	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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of