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

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: GC2129A(Period 1); Drug: Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1); Drug: Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2); Drug: GC2129A(Period 2)

• Registration Number: NCT05729386
• Lead Sponsor: GC Biopharma Corp

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.

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-06
• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-06
• Last Update Submitted: 2023-02-06
• Study First Posted: 2023-02-15
• Last Update Posted: 2023-02-15
• Primary Completion: 2023-04-17
• Study Completion: 2023-04-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GC2129A + Reference drugs	GC2129A(Period 1)	Period 1: GC2129A, Period 2: Individual Components
GC2129A + Reference drugs	Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)	Period 1: GC2129A, Period 2: Individual Components
Reference drugs + GC2129A	Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1)	Period 1: Individual Components, Period 2: GC2129A
Reference drugs + GC2129A	GC2129A(Period 2)	Period 1: Individual Components, Period 2: GC2129A

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) parameters - AUCt	0-48hours	Pharmacokinetic (PK) parameters of Metformin in serum
Pharmacokinetic (PK) parameters - Cmax	0-48hours	Pharmacokinetic (PK) parameters of Metformin in serum

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) parameters - AUCinf	0-48hours	Pharmacokinetic (PK) parameters of Metformin in serum
Pharmacokinetic (PK) parameters - Tmax	0-48hours	Pharmacokinetic (PK) parameters of Metformin in serum
Pharmacokinetic (PK) parameters - t1/2	0-48hours	Pharmacokinetic (PK) parameters of Metformin in serum

Trial Locations

Locations (1)

H Plus YangJi Hospital; 🇰🇷 Seoul, Korea, Republic of