Healthy VolunteersPhase 1NCT05703984
A Study to Evaluate the Safety, PK of GC2129A in Healthy Volunteers Under Fasting Conditions
A Phase 1 study testing GC2129A(Period 1), Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1) and GC2129A(Period 2) in people with Healthy Volunteers, run by GC Biopharma Corp at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and pharmacokinetics of oral administration of GC2129A in fasting conditions to healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GC2129A(Period 1), Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1) and GC2129A(Period 2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jan 2023to 19 Apr 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A person who is 19 years of age or older at the time of a screening visit
- A person with a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less with a weight of 50 kg or more (45 kg or more for women) during a screening visit
- A person who has no clinically significant congenital or chronic disease during a screening visit and has no pathological symptoms or findings as a result of internal examination
Who cannot join
- Persons with clinically significant diseases or history of the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infectious disease, kidney and urinary reproductive system, mental and nervous system, musculoskeletal system, immune system, otolaryngology, skin system, and ophthalmology.
- A person who has a history of gastrointestinal surgery
- Those who have taken drug metabolism enzymes, such as barbiturate drugs, within one month of the first dose date or who have taken drugs that may interfere with this clinical trial within 10 days of the first dose date
- A person who participates in another clinical trial or biological equivalence test within six months of the first administration date
- A person who has donated whole blood within 8 weeks of the date of first administration, or has donated components within 2 weeks, or has received a blood transfusion within 4 weeks
- A person who is deemed unsuitable for participation in this clinical trial by the principle investigator(or the delegated sub-investigator) for reasons other than the above selection and exclusion criteria
- In the case of female volunteers, a pregnant woman or pregnant woman is suspected
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
H Plus YangJi Hospital
Seoul
Jae Woo Kim, M.D., 070-4665-9193, m3116@newyjh.com
Jae Woo Kim, M.D.
About this study
Official title: Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of GC2129A in Healthy Adult Volunteers Under Fasting Conditions
The purpose of this study is to evaluate the safety and pharmacokinetics of oral administration of GC2129A in fasting conditions to healthy adult volunteers.
Read the detailed description
This study is an open-label, randomized, fasting, single-dose, 2-group, 2-period, crossover design to evaluate pharmacokinetics that are not affected by blinding. According to the order of administering the investigational drug for each period, 25 people are assigned to each of the two groups and administered.
For healthy subjects, each 25 subjects are assigned to each of the two groups(total 50 subjects). If the subject administrate GC2129A in the first stage, the subject will be administrated reference drugs in the second stage after washout(over 7 weeks). Conversely, if the subject administrate reference drugs in the first stage, the subject will be administrated with GC2129A in the second stage.
- Conditions
- Healthy Volunteers
- Being tested
- GC2129A(Period 1), Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1), GC2129A(Period 2), Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)
- Keywords
- PK, GC2129A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC2129A(Period 1)Drug
Linagliptin and Metformin Hydrochloride Tablet
Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1)Drug
Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets)
GC2129A(Period 2)Drug
Linagliptin and Metformin Hydrochloride Tablet
Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)Drug
Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets)
| Study group | Role | What they receive |
|---|---|---|
| GC2129A + Reference drugs | Experimental | Period 1: GC2129A Period 2: Individual Components Receives: Drug: GC2129A(Period 1); Drug: Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2) |
| Reference drugs + GC2129A | Experimental | Period 1: Individual Components Period 2: GC2129A Receives: Drug: Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1); Drug: GC2129A(Period 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) parameters - Cmax
Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum
Measured: 0-72hours
Pharmacokinetic (PK) parameters - AUCt
Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum
Measured: 0-72hours
Secondary outcomes (3)
Pharmacokinetic (PK) parameters - AUCinf
Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum
Measured: 0-72hours
Pharmacokinetic (PK) parameters - Tmax
Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum
Measured: 0-72hours
Pharmacokinetic (PK) parameters - t1/2
Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum
Measured: 0-72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start17 Jan 2023
- Primary completion19 Apr 2023 (estimated)
- Study completion19 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by GC Biopharma CorpThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- an open-label, randomized, fasting, single-dose, 2-group, 2-period, crossover design
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GC Biopharma Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703984
- Sponsor's protocol ID
- GC2129A_BE_FAST_P0101
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of GC2129A in Healthy Adult Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT05703984
- Acronym / sponsor ID
- GC2129A_BE_FAST_P0101
- Conditions
- Healthy Volunteers
- Keywords
- PK, GC2129A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- GC Biopharma CorpIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 19 Apr 2023 (estimated)
- Study completion
- 19 Apr 2023 (estimated)
- First posted
- 30 Jan 2023 (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.
The purpose of this study is to evaluate the safety and pharmacokinetics of oral administration of GC2129A in fasting conditions to healthy adult volunteers.
Detailed description
This study is an open-label, randomized, fasting, single-dose, 2-group, 2-period, crossover design to evaluate pharmacokinetics that are not affected by blinding. According to the order of administering the investigational drug for each period, 25 people are assigned to each of the two groups and administered.
For healthy subjects, each 25 subjects are assigned to each of the two groups(total 50 subjects). If the subject administrate GC2129A in the first stage, the subject will be administrated reference drugs in the second stage after washout(over 7 weeks). Conversely, if the subject administrate reference drugs in the first stage, the subject will be administrated with GC2129A in the second stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- an open-label, randomized, fasting, single-dose, 2-group, 2-period, crossover design
| Arm | Type | Receives |
|---|---|---|
| GC2129A + Reference drugs | Experimental | Drug: GC2129A(Period 1), Drug: Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)Period 1: GC2129A Period 2: Individual Components |
| Reference drugs + GC2129A | Experimental | Drug: Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1), Drug: GC2129A(Period 2)Period 1: Individual Components Period 2: GC2129A |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A person who is 19 years of age or older at the time of a screening visit
- A person with a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less with a weight of 50 kg or more (45 kg or more for women) during a screening visit
- A person who has no clinically significant congenital or chronic disease during a screening visit and has no pathological symptoms or findings as a result of internal examination
Key exclusion criteria (7 listed)
- Persons with clinically significant diseases or history of the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infectious disease, kidney and urinary reproductive system, mental and nervous system, musculoskeletal system, immune system, otolaryngology, skin system, and ophthalmology.
- A person who has a history of gastrointestinal surgery
- Those who have taken drug metabolism enzymes, such as barbiturate drugs, within one month of the first dose date or who have taken drugs that may interfere with this clinical trial within 10 days of the first dose date
- A person who participates in another clinical trial or biological equivalence test within six months of the first administration date
- A person who has donated whole blood within 8 weeks of the date of first administration, or has donated components within 2 weeks, or has received a blood transfusion within 4 weeks
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 |
|---|---|---|
| GC2129A(Period 1)Linagliptin and Metformin Hydrochloride Tablet | Drug | GC2129A + Reference drugs |
| Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1)Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets) | Drug | Reference drugs + GC2129A |
| GC2129A(Period 2)Linagliptin and Metformin Hydrochloride Tablet | Drug | Reference drugs + GC2129A |
| Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets) | Drug | GC2129A + Reference drugs |
Primary outcome
Pharmacokinetic (PK) parameters - Cmax
Time frame: 0-72hours
Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum
Pharmacokinetic (PK) parameters - AUCt
Time frame: 0-72hours
Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum
3 secondary outcomes
Pharmacokinetic (PK) parameters - AUCinf
Time frame: 0-72hours
Pharmacokinetic (PK) parameters - Tmax
Time frame: 0-72hours
Pharmacokinetic (PK) parameters - t1/2
Time frame: 0-72hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
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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.
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 GC2129A(Period 1), Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1) and GC2129A(Period 2) in people with Healthy Volunteers, run by GC Biopharma Corp 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 7 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: status not confirmed, as of the sponsor's last update on 30 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GC Biopharma Corp. (82-(0)31-260-1934, juyeon.kim@gccorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic (PK) parameters - Cmax (time frame: 0-72hours). The study lists 2 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 30 Jan 2023.