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

• Sponsor: GC Biopharma Corp (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05729386
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 2.3
• Patients Per Site Per Month: 14.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: GC2129A(Period 1); Drug: Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1); Drug: GC2129A(Period 2); Drug: Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: An open-label, randomized, fed, single-dose, 2-group, 2-period, crossover designAn open-label, randomized, fed, single-dose, 2-group, 2-period, crossover design
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of GC2129A in Healthy Adult Volunteers Under Fed Conditions
• Actual Study Start Date: Feb 6, 2023
• Anticipated Primary Completion Date: Apr 17, 2023
• Anticipated Study Completion Date: Apr 17, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetic (PK) parameters - Cmax [0-48hours]

   Pharmacokinetic (PK) parameters of Metformin in serum

2. Pharmacokinetic (PK) parameters - AUCt [0-48hours]

   Pharmacokinetic (PK) parameters of Metformin in serum

Secondary Outcome Measures

1. Pharmacokinetic (PK) parameters - AUCinf [0-48hours]

   Pharmacokinetic (PK) parameters of Metformin in serum

2. Pharmacokinetic (PK) parameters - Tmax [0-48hours]

   Pharmacokinetic (PK) parameters of Metformin in serum

3. Pharmacokinetic (PK) parameters - t1/2 [0-48hours]

   Pharmacokinetic (PK) parameters of Metformin in serum

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H Plus YangJi Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• GC Biopharma Corp

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GC Biopharma Corp
• ClinicalTrials.gov Identifier: NCT05729386
• Other Study ID Numbers: GC2129A_BE_FED_P0102
• First Posted: Feb 15, 2023
• Last Update Posted: Feb 15, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by GC Biopharma Corp: PK; GC2129A
• Additional relevant MeSH terms: Malnutrition; Metformin

Study Results

No Results Posted as of Feb 15, 2023