Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics and Safety of Orally Administered Radotinib

NCT06461078 | Completed Phase 1

• 1 other identifier: RT51KR-PK01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics and Safety of Orally Administered Radotinib in Healthy Adults

Conditions

Drug Kinetics

Outcome Measures

Primary Outcomes (2)

• Cmax(Maximum concentration of drug in plasma)

  Pre-dose(0 hour), after dose 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 18 hours, 24 hours, 32 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours

• AUClast(Area under the plasma drug concentration-time curve to last concentration) of Radotinib

  Pre-dose(0 hour), after dose 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 18 hours, 24 hours, 32 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours

Secondary Outcomes (7)

• AUCinf(Area under the plasma drug concentration-time curve from 0 to infinity) of Radotinib

  Pre-dose(0 hour), after dose 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 18 hours, 24 hours, 32 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours

• Tmax(Time to maximum plasma concentration) of Radotinib

  Pre-dose(0 hour), after dose 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 18 hours, 24 hours, 32 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours

• t1/2(Terminal elimination half-life) of Radotinib

  Pre-dose(0 hour), after dose 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 18 hours, 24 hours, 32 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours

• Vd/F(Apparent volume of distribution), CL/F(Apparent clearance) of Radotinib

  Pre-dose(0 hour), after dose 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 18 hours, 24 hours, 32 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours

• Cmax of Radotinib metabolites(M1, M2)

  Pre-dose(0 hour), after dose 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 18 hours, 24 hours, 32 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours

Study Arms (2)

Active Comparator: Treatment Group

ACTIVE COMPARATOR

Radotinib 200mg, 2 Tablets, Fasting, Single dose

Drug: Radotinib HCl

Active Comparator: Control Group

ACTIVE COMPARATOR

Radotinib 200mg, 2 Tablets, Standard diet, Single dose

Drug: Radotinib HCl

Interventions

Radotinib HCl DRUG

1. Brand name/manufacturer: Supect Cap./IL-YANG PHARM. Co., Ltd. 2. Active ingredient: radotinib HCl 106.8mg (100mg as radotinib) or HCl 213.6mg (200mg as radotinib) 3. Appearance and formulation: hard capsule with a light blue cap and a body containing pale yellow powder 4. Storage conditions: Store in an airtight light proof container at room temperature.

Also known as: SUPECT

Active Comparator: Control Group; Active Comparator: Treatment Group

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged 19 or older and 55 or younger at the time of screening tests.
• Men weigh more than 55 kg and women weigh more than 50 kg.
• Those who have a body mass index of 18.5 kg/m2 or more and less than 27.0 kg/m2.
• ※ Body mass index (body mass index, kg/m2) = Weight (kg)/\[Height (m)\]2
• If participants are a woman, participants must apply to one of the following.
• Menopause (no natural menstruation for at least 2 years)
• Surgical infertility (hysterectomy or bilateral oophorectomy, tubal ligation, or other infertility)
• If a male has sex with a female of childbearing age, he/she must agree to use contraception\* until at least 28 days after the clinical trial period and the final administration of the clinical trial drug and not to donate sperm.
• \*Contraception: Use a combination of vasectomy, intrauterine device, tubal ligation and blocking contraception (male condom, female condom, cervical cap, contraceptive septum, sponge, etc.) or use a combination of two or more blocking contraception when using a biocidal agent.
• A subject who has fully understood and received sufficient explanation of this clinical trial and has voluntarily decided to participate and agreed in writing to comply with the precautions.

You may not qualify if:

• A person with a history of clinically significant hepatobiliary system (severe hepatic disorder, hyperbilirubinemia, pancreatitis, etc.), kidney (severe renal disorder, acute renal failure, etc.), urethral disorder, nervous system, immune system, respiratory system, endocrine system, cardiovascular system (myocardial infarction, congestive heart failure, unstable angina, bradycardia, long QT syndrome, torsade de points, etc.), blood, tumor, urinary system, psychiatric disorder, or medical history.
• Those with a history of gastrointestinal diseases (Crohn's disease, ulcerative colitis, etc.) or surgery (except for simple appendectomy or hernia surgery) that can affect the absorption of drugs.
• A person who has a history of clinically significant hypersensitivity reactions or allergies to drugs or additives (Yellow 5, Sunset Yellow FCF), including ingredients (Radotinib) of clinical trial drugs.
• A person who was judged to be inappropriate as a test subject in a screening test conducted within 28 days prior to administration of a clinical drug (examination, blood pressure, 12-lead electrocardiogram, physical examination, clinical laboratory examination, etc.).
• In the case of \> 1.5 times the upper limit of AST and ALT normal range in the blood
• In the case of \> 1.5 times the upper limit of Total bilirubin normal range in the blood
• Estimated Global Film Rate (eGFR) \<60 mL/min/1.73 m2 using the Modification of Diet in Regular Disease (MDRD) formula
• Serum test (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test) result are positive factors
• QTcF \> 480 msec on electrocardiogram
• After resting for at least 5 minutes, those who showed a value corresponding to systolic blood pressure\>150 mmHg or \<90 mmHg, diastolic blood pressure\>100 mmHg or \<50 mmHg in the vital signs measured at the seat
• A person who shows suspected symptoms of acute illness (chilliness, fever, diarrhea, stomatitis, redness, infectious symptoms, etc.) at the time of screening tests.
• A person who has a history of drug abuse or has tested positive in a urine drug screening test within one year of screening.
• If the tester determines that the following drugs, excluding topical drugs without significant systemic absorption, may affect this test or affect the safety of the test subject within the relevant period.
• In the case of taking general medicines including health foods and vitamin preparations within 7 days prior to the first administration of clinical trial drugs
• In the case of taking a prescription drug or herbal medicine within 14 days prior to the first administration date of the clinical trial drug

Sponsors & Collaborators

• Il-Yang Pharm. Co., Ltd.: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

Study Officials

• Minsoo Park, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Open-label, Single-dose, Two-way Crossover

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 14, 2024
• Study Start: July 22, 2024
• Primary Completion: September 25, 2024
• Study Completion: April 28, 2025
• Last Updated: April 30, 2025

Record last verified: 2024-06

Locations

KR (1)