HealthyPhase 1NCT05370716
Drug-Drug Interaction Study of "CG-651" in Healthy Volunteer
A Phase 1 study testing Polmacoxib and Pregabalin in people with Healthy, run by CrystalGenomics, Inc. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Polmacoxib and Pregabalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Nov 2019to 19 May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Healthy
- Being tested
- Polmacoxib, Pregabalin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolmacoxibDrug
Polmacoxib
PregabalinDrug
Pregabalin
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Pregabalin + Polmacoxib Receives: Drug: Polmacoxib; Drug: Pregabalin |
| Group B | Active comparator | Polmacoxib Receives: Drug: Polmacoxib |
| Group C | Active comparator | Pregabalin Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of polmacoxib and pregabalin
Maximum Observed Plasma Concentration
Measured: upto 4 weeks
AUC of polmacoxib and pregabalin
Area Under the Concentration-Time Curve
Measured: 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.
Measured: upto 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start11 Nov 2019
- Primary completion30 Apr 2020
- Study completion19 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Group A: Pregabalin + Polmacoxib * Group B: Polmacoxib * Group C: Pregabalin
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- CrystalGenomics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370716
- Sponsor's protocol ID
- CG100651-1-01
- Status last verified
- May 2022
- First submitted
- 3 Dec 2019
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05370716
- Acronym / sponsor ID
- CG100651-1-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- CrystalGenomics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 19 May 2020 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- * Group A: Pregabalin + Polmacoxib * Group B: Polmacoxib * Group C: Pregabalin
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Polmacoxib, Drug: PregabalinPregabalin + Polmacoxib |
| Group B | Active comparator | Drug: PolmacoxibPolmacoxib |
| Group C | Active comparator | Drug: PregabalinPregabalin |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolmacoxibPolmacoxib | Drug | Group A, Group B |
| PregabalinPregabalin | Drug | Group A, Group C |
Primary outcome
Cmax of polmacoxib and pregabalin
Time frame: upto 4 weeks
Maximum Observed Plasma Concentration
AUC of polmacoxib and pregabalin
Time frame: upto 4 weeks
Area Under the Concentration-Time Curve
The Number of Participants Who Experienced Adverse events (AEs)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Polmacoxib and Pregabalin in people with Healthy, run by CrystalGenomics, Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of polmacoxib and pregabalin (time frame: upto 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.