An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I)

LG Chem

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Gemiglptin 50mg multiple dose; Drug: Gemigliptin 50mg; Drug: Gemigliptin 25mg; Drug: Gemigliptin 100mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03864432

LG-DPCL020

Details and patient eligibility

About

To determine the pharmacokinetic properties, safety and tolerability of single/multiple oral administration of Gemigliptin and Food effect in healthy Chinese subjects.

Enrollment: 48 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female subjects (aged 19~45 years at the time of screening)
• Subjects weighing between 50kg (inclusive) and 90kg (exclusive), and having a body mass index (BMI) of 17.1～25.8 (inclusive of limits).
• Subjects with a fasting plasma glucose (FPG) of 70～110mg/dL (inclusive of limits) at the time of screening
• Subjects who are willing to participate in the entire study cycle and comply with the study protocol (including contraception). Subjects who can sign the written Informed Consent Form after being informed of the study procedures.

Exclusion criteria

• Those with a history of allergies including drug allergies (aspirin, antibiotics, etc.), or other clinically significant allergies.
• Those with diseases of the liver (including carriers of hepatitis virus), kidney, respiratory system, endocrine system, nervous system or immune system. Those with a medical history of hematology/oncology, psychiatry or cardiovascular diseases.
• Those with a medical history of gastrointestinal diseases (ulcers, Crohn's disease, etc.) or surgery (excluding simple appendectomy or hernia repair), and these situations can affect the absorption of the study drug.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

48 participants in 4 patient groups

25mg SAD

Experimental group

Treatment:

Drug: Gemigliptin 25mg

50mg SAD

Experimental group

Treatment:

Drug: Gemigliptin 50mg

100mg SAD

Experimental group

Treatment:

Drug: Gemigliptin 100mg

50mg Multiple dosing

Experimental group

Treatment:

Drug: Gemiglptin 50mg multiple dose