Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects

NCT05604287 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: ID119031166M-NASH-101
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants.

Conditions

Healthy Participants

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)

  To evaluate the safety and tolerability of single and multiple ascending doses of ID119031166M in healthy participants.

  From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 22 for MAD)

Secondary Outcomes (6)

• Maximum plasma concentration determined directly from the concentration- time profile (Cmax)

  Day 1-4 for SAD and Day 1-17 for MAD

• Time of maximum plasma concentration determined directly from the concentration-time profile (Tmax)

  Day 1-4 for SAD and Day 1-17 for MAD

• 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

• Dose-normalized Cmax

  Day 1-4 for SAD and Day 1-17 for MAD

• 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

Study Arms (4)

SAD: ID119031166M

EXPERIMENTAL

Drug: ID119031166M

MAD: ID119031166M

EXPERIMENTAL

Drug: ID119031166M

SAD: Placebo

PLACEBO COMPARATOR

Drug: Placebo

MAD: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ID119031166M DRUG

The participants will receive a single oral dose of ID119031166M or once daily oral doses of ID119031166M for 14 days.

MAD: ID119031166M; SAD: ID119031166M

Placebo DRUG

The participant will receive a oral dose of Placebo.

MAD: Placebo; SAD: Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead
• Parexel: collaborator
• YUNOVIA CO.,LTD.: collaborator

Study Sites (1)

California Clinical trials medical group/PAREXEL

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 3, 2022
• Study Start: October 10, 2022
• Primary Completion: April 12, 2024
• Study Completion: April 12, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

US (1)