A Study of LC542019 in Healthy Subjects and Subjects With T2DM

Healthy Clinical Trial

Official title:

A First in Human, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LC542019 in Healthy Subjects and Subjects With T2DM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06333977
• Other study ID #: LG-GQCL001
• Status: Completed
• Phase: Phase 1
• Start date: March 25, 2022
• Est. completion date: December 14, 2023

Study information

• Verified date: March 2024
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics in healthy subjects and subjects with type 2 diabetes (T2DM).

Description:

The study will be conducted in 2 parts:

Part 1 (Single Ascending Dose) This part will include 6 sequential dose cohorts (S1-S6).

Part 2 (Multiple Ascending Dose) This part will include 5 sequential dose cohorts (M1-M5). Cohorts M1-M4 will enroll healthy subjects. Cohort M5 will enroll subjects with T2DM.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 14, 2023
• Est. primary completion date: December 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

For healthy subjects:

Inclusion criteria

• Adults = 18 to = 55 years.

• Body mass index (BMI) =18.5 to = 30.0 kg/m2

• Female subjects must be non-pregnant and non-lactating. Females of childbearing potential must use at least two of the medically accepted contraceptive methods, table at least 4 weeks prior to the screening.

• Ability to provide written informed consent.

Exclusion Criteria

• History of or current diagnosis of Diabetes Mellitus Type 1 or Diabetes Mellitus Type 2

• History of or current significant diagnosis of cardiovascular, respiratory, hepatic, renal, gastrointestinal endocrine, hematological, or neurological disorders or abnormalities, or other major systemic disease

• History of or presence of clinically significant ECG findings

• History of or acute significant gastrointestinal disorder

For T2DM subjects:

Inclusion criteria

• Adults = 18 to = 70 years.

• Body mass index (BMI) =18.5 to = 35.0 kg/m2 with stable body weight by history for 3 months

• Subjects with T2DM > 6 months, on stable therapy with metformin monotherapy.

• Female subjects must be non-pregnant and non-lactating. Females of childbearing potential must use at least two of the medically accepted contraceptive methods, table at least 4 weeks prior to the screening.

• Ability to provide written informed consent.

Exclusion Criteria

• History of or current diagnosis of Diabetes Mellitus Type 1

• A subject who has acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, especially autonomic neuropathy

• Recurrent major hypoglycemia or hypoglycemic unawareness or recent ketoacidosis

• Current use of any prescribed or non-prescribed drugs (other than current treatment for diabetes mellitus or birth control methods)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Healthy

Intervention

Drug:
• LC542019
oral dose, once daily
• Placebo
matching placebo

Locations

Country	Name	City	State
United States	PPD Development, LP (PPD Clinical Research Unit, Las Vegas)	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiodynamic evaluation	concentration-QTc analysis	up to 4 weeks
Other	Fasting Plasma Glucose		up to 4 weeks
Other	HbA1c		up to 4 weeks
Primary	Incidence, severity of adverse events		up to 4 weeks
Secondary	Maximum Concentration (Cmax) in Plasma		up to 4 weeks
Secondary	Renal Clearance (CLR) in urine		up to 2 weeks