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

Sponsor
CrystalGenomics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05370716
Collaborator
(none)
47
Enrollment
1
Location
3
Arms
6.2
Actual Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Group A: Pregabalin + Polmacoxib Group B: Polmacoxib Group C: PregabalinGroup A: Pregabalin + Polmacoxib Group B: Polmacoxib Group C: Pregabalin
Masking:
None (Open Label)
Masking Description:
None (open label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label, Multiple-dose, Parallel Study to Compare the Pharmacokinetics and to Evaluate Drug-Drug Interaction of "CG-651" in Healthy Volunteers
Actual Study Start Date :
Nov 11, 2019
Actual Primary Completion Date :
Apr 30, 2020
Actual Study Completion Date :
May 19, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

Pregabalin + Polmacoxib

Drug: Polmacoxib
Polmacoxib

Drug: Pregabalin
Pregabalin
Active Comparator: Group B

Polmacoxib

Drug: Polmacoxib
Polmacoxib
Active Comparator: Group C

Pregabalin

Drug: Pregabalin
Pregabalin

Outcome Measures

Primary Outcome Measures

  1. Cmax of polmacoxib and pregabalin [upto 4 weeks]

    Maximum Observed Plasma Concentration

  2. AUC of polmacoxib and pregabalin [upto 4 weeks]

    Area Under the Concentration-Time Curve

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Key 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 03080

Sponsors and Collaborators

  • CrystalGenomics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CrystalGenomics, Inc.
ClinicalTrials.gov Identifier:
NCT05370716
Other Study ID Numbers:
  • CG100651-1-01
First Posted:
May 11, 2022
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pregabalin

Study Results

No Results Posted as of May 31, 2022