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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: GC2129A(Period 1); Drug: Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2); Drug: Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1); Drug: GC2129A(Period 2)

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • H plus Yangji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GC2129A + Reference drugs; Period 1: GC2129A Period 2: Individual Components	Drug: GC2129A(Period 1); Linagliptin and Metformin Hydrochloride Tablet; Drug: Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2); Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets)
Experimental: Reference drugs + GC2129A; Period 1: Individual Components Period 2: GC2129A	Drug: Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1); Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets); Drug: GC2129A(Period 2); Linagliptin and Metformin Hydrochloride Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) parameters - Cmax	Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum	0-72hours
Pharmacokinetic (PK) parameters - AUCt	Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum	0-72hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) parameters - AUCinf	Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum	0-72hours
Pharmacokinetic (PK) parameters - Tmax	Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum	0-72hours
Pharmacokinetic (PK) parameters - t1/2	Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum	0-72hours

Collaborators and Investigators

• Sponsor: GC Biopharma Corp

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Anticipated): April 19, 2023
• Study Completion (Anticipated): April 19, 2023

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Estimate): January 30, 2023

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: PK; GC2129A
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: GC2129A_BE_FAST_P0101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No