Diabetes Mellitus, Type 2, Healthy
Conditions
Brief summary
to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics in healthy subjects and subjects with type 2 diabetes (T2DM).
Detailed 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.
Interventions
DRUGLC542019
oral dose, once daily
DRUGPlacebo
matching placebo
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, severity of adverse events | up to 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Concentration (Cmax) in Plasma | up to 4 weeks |
| Renal Clearance (CLR) in urine | up to 2 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cardiodynamic evaluation | up to 4 weeks | concentration-QTc analysis |
| Fasting Plasma Glucose | up to 4 weeks | — |
| HbA1c | up to 4 weeks | — |
Countries
United States
Outcome results
None listed