Seoul National University Hospital
Seoul, 03080, South Korea
Location status: Recruiting
Recruiting
NCT Number: NCT06635226
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ID110521156 in Healthy Adult Subjects
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of ID110521156 in healthy adult subjects.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
19 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
ID110521156
DrugID110521156 capsules taken orally once daily
Placebo of 110521156
DrugID110521156 placebo capsules taken orally once daily
Primary outcomes
-
AEs/serious AEs (SAEs)
Time frame: Throughout study duration, up to 47 days
Secondary outcomes
-
Maximum concentration of drug in plasma (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Day 1 and Day 28
To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
-
Renal clearance (CLR)
Time frame: Day 1 and Day 28
To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
-
fe
Time frame: Day 1 and Day 28
To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
-
Trough plasma concentration taken directly before the next dose (Ctrough)
Time frame: Throughout study duration, up to 27 days
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)
Time frame: 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)
Time frame: Day 28
To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.
-
peak to trough fluctuation (PTF)
Time frame: Day 28
To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.
-
accumulation ratio (R)
Time frame: Day 28
To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.
-
Serum glucose
Time frame: up to 28 days
To assess the pharmacodynamics of ID110521156 when given at single and multiple ascending doses in healthy participants.
-
Insulin
Time frame: up to 28 days
To assess the pharmacodynamics of ID110521156 when given at single and multiple ascending doses in healthy participants.
-
Hemoglobin A1c (HbA1c)
Time frame: up to 47 days
To assess the pharmacodynamics of ID110521156 when given at multiple ascending doses in healthy participants.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
IlDong Pharmaceutical Co Ltd
Industry
Collaborators
- YUNOVIA CO.,LTD.
Registry information
Official study title
A Randomized, Double-blinded, Placebo-controlled, Multiple Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Oral Administrations of ID110521156 in Healthy Subjects
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Oct 10, 2024
- Registry last updated
- Dec 24, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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