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

NCT ID: NCT05604287

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-10
• Study Completion Date: 2024-04-12

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).

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SAD: ID119031166M

Group Type: EXPERIMENTAL

ID119031166M

Intervention Type: DRUG

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

MAD: ID119031166M

Group Type: EXPERIMENTAL

ID119031166M

Intervention Type: DRUG

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

SAD: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The participant will receive a oral dose of Placebo.

MAD: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The participant will receive a oral dose of Placebo.

Interventions

ID119031166M

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

Intervention Type: DRUG

Placebo

The participant will receive a oral dose of Placebo.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

YUNOVIA CO.,LTD.

UNKNOWN

Sponsor Role: collaborator

IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

California Clinical trials medical group/PAREXEL

Glendale, California, United States

Countries

United States

Other Identifiers

ID119031166M-NASH-101

Identifier Type: -

Identifier Source: org_study_id