Healthy Participants
Conditions
Keywords
First-in-human (FIH), Single ascending doses (SAD), Multiple ascending doses (MAD), Farnesoid X receptor (FXR) agonist, Noncirrhotic non-alcoholic steatohepatitis (NASH), Liver fibrosis
Brief summary
This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants.
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, sequential single/repeated-dose study. This study is a dose-escalation study with healthy participants in single ascending dose (SAD) including food-effect and multiple ascending dose (MAD) cohorts to determine the highest allowable dose (HAD).
Interventions
DRUGID119031166M
The participants will receive a single oral dose of ID119031166M or once daily oral doses of ID119031166M for 14 days.
DRUGPlacebo
The participant will receive a oral dose of Placebo.
Sponsors
Parexel
YUNOVIA CO.,LTD.
IlDong Pharmaceutical Co Ltd
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
* Must be Caucasian (White American of European or Latin American descent). * Healthy participants of Japanese origin are allowed up to 50% in each MAD cohort. * Body mass index (BMI) within the range of 18.5 to 30 kg/m\^2 (inclusive) at the time of Screening. * No congenital or chronic diseases that require treatment and without pathologic symptoms or signs on medical examinations. * Participants with normal renal function. * Women are eligible to participate if not pregnant, not breastfeeding. Male subjects should be willing to use 'highly effective' or 'applicable' contraceptive methods.
Exclusion criteria
* Currently have an acute disease with active symptoms. * History of melanoma or other skin issues (including, but not limited to pre-cancerous areas, atopic dermatitis, psoriasis, rosacea, excessive moles etc.). * History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal, or cardiovascular disease and/or arrhythmias. * History of clinically significant hypersensitivity reaction to any drugs or additives. * History of any gastrointestinal disease. * History of substance use disorder including history of drug abuse disorder or history of alcohol use disorder, or tobacco use disorder or excessive caffeine intake. * Evidence of moderate or excessive alcohol consumption. * Tested positive in viral serology tests (hepatitis B virus \[HBV\], hepatitis C virus \[HCV\], and human immunodeficiency virus \[HIV\]). * Known family history or known presence of long QT syndrome. * A history of hypokalemia. * Use of concomitant medicines that prolong QT/QTc (QT Interval Corrected for Heart Rate). * History of active viral hepatitis (hepatitis A, B, C, and E), or autoimmune hepatitis. * History of Multiple Endocrine Neoplasia type 2. * Solid organ transplantation, except corneal transplants. * History or presence of neutropenia which is defined as absolute neutrophil count (ANC) \< 1.5 at Screening and admission. * Participants with a microalbuminuria. * Hemoglobin levels below 12.0 g/dL at Screening or Baseline. * White Blood Cell levels below 3.5 × 109/L at Screening or Baseline. * Platelet count \< 150,000/µL, international normalized ratio (INR) \> 1.5, albumin \< 3.5 g/dL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs) | From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 22 for MAD) | To evaluate the safety and tolerability of single and multiple ascending doses of ID119031166M in healthy participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of maximum plasma concentration determined directly from the concentration-time profile (Tmax) | Day 1-4 for SAD and Day 1-17 for MAD | To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. To explore food effect on PK of ID119031166M after a single-dose administration in healthy participants. |
| Area under curve from pre-dose (time 0) to the time of the last quantifiable concentration (tlast) (AUC0-last) | Day 1-4 for SAD and Day 1-17 for MAD | To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. |
| Maximum plasma concentration determined directly from the concentration- time profile (Cmax) | Day 1-4 for SAD and Day 1-17 for MAD | To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. To explore food effect on PK of ID119031166M after a single-dose administration in healthy participants. |
| Dose-normalized AUC from pre-dose (time 0) extrapolated to 24 hours (AUC0-24) | Day 1-4 for SAD and Day 1-17 for MAD | To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. |
| Dose-normalized AUC0-last | Day 1-4 for SAD and Day 1-17 for MAD | To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. |
| Dose-normalized Cmax | Day 1-4 for SAD and Day 1-17 for MAD | To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. |
Countries
United States
Outcome results
None listed