Healthy Adult Subjects
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of ID110521156 in healthy adult subjects.
Interventions
DRUGID110521156
ID110521156 capsules taken orally once daily
DRUGPlacebo of 110521156
ID110521156 placebo capsules taken orally once daily
Sponsors
YUNOVIA CO.,LTD.
IlDong Pharmaceutical Co Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects aged 19 to 50 years at the time of Screening. * Body mass index (BMI) within ≥27 kg/m2; and a total body weight ≥ 50 kg * Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study * For female subjects, not pregnant or lactation women, or naturally menopausal (spontaneous amenorrhea for at least 12 months) or surgically infertility (bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy etc).
Exclusion criteria
* Evidence or history of clinically significant hepatic, renal, neurological, immunological, pulmonary, gastrointestinal (including pancreatitis), endocrine, hematological, cardiovascular, urinary, psychiatric disease, sexual dysfunction or drug allergies. * Treatment with an investigational drug (including a bioequivalence study) within 180 days prior to the scheduled date of first administration of the investigational product. * Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 90 days after the last dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AEs/serious AEs (SAEs) | Throughout study duration, up to 47 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal clearance (CLR) | Day 1 and Day 28 | To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants. |
| Apparent volume of distribution after extravascular administration (Vd/F) | Day 1 and Day 28 | To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants. |
| Terminal half-life (t1/2) | Day 1 and Day 28 | To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants. |
| Apparent clearance (CL/F) | Day 1 and Day 28 | To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants. |
| Maximum concentration of drug in plasma (Cmax) | Day 1 and Day 28 | To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants. |
| Area under the plasma drug concentration-time curve during a dosing interval (AUCtau) | Day 1 and Day 28 | To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants. |
| The time of peak concentration (Tmax) | Day 1 and Day 28 | To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants. |
| fe | Day 1 and Day 28 | To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants. |
| Minimum concentration of drug in plasma at steady state (Cmin, ss) | Day 28 | To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants. |
| Average concentration of drug in plasma at steady state (Cavg, ss) | Day 28 | To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants. |
| peak to trough fluctuation (PTF) | Day 28 | To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants. |
| accumulation ratio (R) | Day 28 | To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants. |
| Serum glucose | up to 28 days | To assess the pharmacodynamics of ID110521156 when given at single and multiple ascending doses in healthy participants. |
| Insulin | up to 28 days | To assess the pharmacodynamics of ID110521156 when given at single and multiple ascending doses in healthy participants. |
| Hemoglobin A1c (HbA1c) | up to 47 days | To assess the pharmacodynamics of ID110521156 when given at multiple ascending doses in healthy participants. |
| Trough plasma concentration taken directly before the next dose (Ctrough) | Throughout study duration, up to 27 days | To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants. |
Countries
South Korea
Contacts
Primary ContactClinical Ops Study Leader
Outcome results
None listed