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A Study to Evaluate the Safety, PK of GC2129A in Healthy Volunteers Under Fed Conditions

Primary Purpose

Healthy Volunteers

Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GC2129A(Period 1)
Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1)
GC2129A(Period 2)
Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)
Sponsored by
GC Biopharma Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteers focused on measuring PK, GC2129A

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • H Plus YangJi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

GC2129A + Reference drugs

Reference drugs + GC2129A

Arm Description

Period 1: GC2129A, Period 2: Individual Components

Period 1: Individual Components, Period 2: GC2129A

Outcomes

Primary Outcome Measures

Pharmacokinetic (PK) parameters - Cmax
Pharmacokinetic (PK) parameters of Metformin in serum
Pharmacokinetic (PK) parameters - AUCt
Pharmacokinetic (PK) parameters of Metformin in serum

Secondary Outcome Measures

Pharmacokinetic (PK) parameters - AUCinf
Pharmacokinetic (PK) parameters of Metformin in serum
Pharmacokinetic (PK) parameters - Tmax
Pharmacokinetic (PK) parameters of Metformin in serum
Pharmacokinetic (PK) parameters - t1/2
Pharmacokinetic (PK) parameters of Metformin in serum

Full Information

First Posted
February 6, 2023
Last Updated
February 6, 2023
Sponsor
GC Biopharma Corp
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1. Study Identification

Unique Protocol Identification Number
NCT05729386
Brief Title
A Study to Evaluate the Safety, PK of GC2129A in Healthy Volunteers Under Fed Conditions
Official Title
Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of GC2129A in Healthy Adult Volunteers Under Fed Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
April 17, 2023 (Anticipated)
Study Completion Date
April 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GC Biopharma Corp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
Keywords
PK, GC2129A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
An open-label, randomized, fed, single-dose, 2-group, 2-period, crossover design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GC2129A + Reference drugs
Arm Type
Experimental
Arm Description
Period 1: GC2129A, Period 2: Individual Components
Arm Title
Reference drugs + GC2129A
Arm Type
Experimental
Arm Description
Period 1: Individual Components, Period 2: GC2129A
Intervention Type
Drug
Intervention Name(s)
GC2129A(Period 1)
Intervention Description
Linagliptin and Metformin Hydrochloride Tablet
Intervention Type
Drug
Intervention Name(s)
Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1)
Intervention Description
Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets)
Intervention Type
Drug
Intervention Name(s)
GC2129A(Period 2)
Intervention Description
Linagliptin and Metformin Hydrochloride Tablet
Intervention Type
Drug
Intervention Name(s)
Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)
Intervention Description
Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets)
Primary Outcome Measure Information:
Title
Pharmacokinetic (PK) parameters - Cmax
Description
Pharmacokinetic (PK) parameters of Metformin in serum
Time Frame
0-48hours
Title
Pharmacokinetic (PK) parameters - AUCt
Description
Pharmacokinetic (PK) parameters of Metformin in serum
Time Frame
0-48hours
Secondary Outcome Measure Information:
Title
Pharmacokinetic (PK) parameters - AUCinf
Description
Pharmacokinetic (PK) parameters of Metformin in serum
Time Frame
0-48hours
Title
Pharmacokinetic (PK) parameters - Tmax
Description
Pharmacokinetic (PK) parameters of Metformin in serum
Time Frame
0-48hours
Title
Pharmacokinetic (PK) parameters - t1/2
Description
Pharmacokinetic (PK) parameters of Metformin in serum
Time Frame
0-48hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GC Biopharma Corp.
Phone
82-(0)31-260-1934
Email
juyeon.kim@gccorp.com
First Name & Middle Initial & Last Name or Official Title & Degree
GC Biopharma Corp.
Phone
82-(0)31-260-9318
Email
yumi@gccorp.com
Facility Information:
Facility Name
H Plus YangJi Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Woo Kim, M.D.
Phone
070-4665-9193
Email
m3116@newyjh.com
First Name & Middle Initial & Last Name & Degree
Jae Woo Kim, M.D.

12. IPD Sharing Statement

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A Study to Evaluate the Safety, PK of GC2129A in Healthy Volunteers Under Fed Conditions

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