A Study to Evaluate the Safety, PK of GC2129A in Healthy... | NCT05729386

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 6, 2023Actual

Primary Completion Date

Apr 17, 2023Estimated

Completion Date

Apr 17, 2023Estimated

First Submitted Date

Feb 6, 2023

First Submission Date that Met QC Criteria

Feb 6, 2023

First Posted Date

Feb 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2023

Last Update Posted Date

Feb 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of oral administration of GC2129A in fed 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, 17 people are assigned to each of the two groups and administered.

For healthy subjects, each 17 subjects are assigned to each of the two groups(total 34 subjects). If the subject administrate GC2129A in the first period, the subject will be administrated reference drugs in the second period after washout(over 7 days). Conversely, if the subject administrate reference drugs in the first period, the subject will be administrated with GC2129A in the second period.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GC2129A + Reference drugs	Experimental	Period 1: GC2129A, Period 2: Individual Components	Drug: GC2129A(Period 1) Drug: Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)
Reference drugs + GC2129A	Experimental	Period 1: Individual Components, Period 2: GC2129A	Drug: Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1) Drug: GC2129A(Period 2)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GC2129A(Period 1)	Drug	Linagliptin and Metformin Hydrochloride Tablet	GC2129A + Reference drugs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic (PK) parameters - Cmax	Pharmacokinetic (PK) parameters of Metformin in serum	0-48hours
Pharmacokinetic (PK) parameters - AUCt	Pharmacokinetic (PK) parameters of Metformin in serum	0-48hours

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic (PK) parameters - AUCinf	Pharmacokinetic (PK) parameters of Metformin in serum	0-48hours
Pharmacokinetic (PK) parameters - Tmax	Pharmacokinetic (PK) parameters of Metformin in serum

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
GC Biopharma Corp.	Contact	82-(0)31-260-1934		juyeon.kim@gccorp.com
GC Biopharma Corp.	Contact	82-(0)31-260-9318		yumi@gccorp.com

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals