Drug KineticsPhase 1NCT06461078
Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics and Safety of Orally Administered Radotinib
A Phase 1 study testing Radotinib HCl in people with Drug Kinetics, run by Il-Yang Pharm. Co., Ltd. at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Kinetics
- What is being tested?
- Radotinib HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jul 2024to 28 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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
- A person who has administered a CYP3A4 inhibitor (ketoconazole, itraconazole, erythromycin, clarithromycin, etc.) or a CYP3A4 inhibitor (dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, St. John's short [hypericum perforatum], etc.) within 30 days prior to the first administration of clinical trial drug
- A person who has administered antiarrhythmic drugs (amiodarone, disopyramid, propofol, quinidine, totalol, etc.) or other drugs that can extend the QT interval (chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin, bepridil, pimozide, etc.) within 30 days prior to the first administration of clinical trial drug
- A person who has received a P-glycoprotein derivative such as ritonavir within 30 days prior to the first day of administration of a clinical trial drug
- A person who has consumed grapefruit-containing food within 7 days prior to the first administration date of clinical trial drugs or cannot be prohibited from taking it during the clinical trial period.
- A person who continuously smoked excessively or consumed caffeine or alcohol (caffeine: >5 cups/day, alcohol: >210 g/week, tobacco: >10 g/day) or who cannot stop smoking, caffeine and alcohol consumption during each hospitalization period.
- A person who participated in another clinical trial (including a bioequivalence test) within 180 days prior to the first administration date of the clinical trial drug and received the clinical trial drug (in the case of biological agents, it may be based on an extended period considering a half-life).
- A person who donated whole blood within 60 days prior to the first administration date of clinical trial drugs or donated component blood within 30 days.
- A person who received a blood transfusion within 30 days prior to the first administration date of the clinical trial drug.
- Pregnant or lactating female at the time of screening tests.
- A person who determines that the tester is inappropriate to participate in clinical trials due to other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- Radotinib HCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radotinib HClDrug
Also called SUPECT
- Brand name/manufacturer: Supect Cap./IL-YANG PHARM. Co., Ltd.
- Active ingredient: radotinib HCl 106.8mg (100mg as radotinib) or HCl 213.6mg (200mg as radotinib)
- Appearance and formulation: hard capsule with a light blue cap and a body containing pale yellow powder
- Storage conditions: Store in an airtight light proof container at room temperature.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Treatment Group | Active comparator | Radotinib 200mg, 2 Tablets, Fasting, Single dose Receives: Drug: Radotinib HCl |
| Active Comparator: Control Group | Active comparator | Radotinib 200mg, 2 Tablets, Standard diet, Single dose Receives: Drug: Radotinib HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax(Maximum concentration of drug in plasma)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Tmaxof Radotinib metabolites(M1, M2)
Measured: 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, metabolic ratio(AUClast of metabolite/AUClast of Radotinib) of Radotinib metabolites(M1, M2)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start22 Jul 2024
- Primary completion25 Sep 2024
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug KineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, Open-label, Single-dose, Two-way Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minsoo Park, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461078
- Sponsor's protocol ID
- RT51KR-PK01
- Status last verified
- Jun 2024
- First submitted
- 29 May 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee Y, Kim J, Kang M, Han J, Kim NY, Shin JS, Park MS, Jiang Q, Lee JI. Clinical pharmacokinetic characteristics and the food effect of radotinib. Invest New Drugs. 2026 Apr;44(2):187-195. doi: 10.1007/s10637-026-01610-6. Epub 2026 Mar 27.
PubMed 41894126
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06461078
- Acronym / sponsor ID
- RT51KR-PK01
- Conditions
- Drug Kinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Open-label, Single-dose, Two-way Crossover
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Treatment Group | Active comparator | Drug: Radotinib HClRadotinib 200mg, 2 Tablets, Fasting, Single dose |
| Active Comparator: Control Group | Active comparator | Drug: Radotinib HClRadotinib 200mg, 2 Tablets, Standard diet, Single dose |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.).
- A person who shows suspected symptoms of acute illness (chilliness, fever, diarrhea, stomatitis, redness, infectious symptoms, etc.) at the time of screening tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radotinib HClAlso: SUPECT1. 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. | Drug | Active Comparator: Control Group, Active Comparator: Treatment Group |
Primary outcome
Cmax(Maximum concentration of drug in plasma)
Time frame: 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
Time frame: 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
7 secondary outcomes
AUCinf(Area under the plasma drug concentration-time curve from 0 to infinity) of Radotinib
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Tmaxof Radotinib metabolites(M1, M2)
Time frame: 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, metabolic ratio(AUClast of metabolite/AUClast of Radotinib) of Radotinib metabolites(M1, M2)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Derived from this study: PubMed 41894126Lee Y, Kim J, Kang M, Han J, Kim NY, Shin JS, Park MS, Jiang Q, Lee JI. Clinical pharmacokinetic characteristics and the food effect of radotinib. Invest New Drugs. 2026 Apr;44(2):187-195. doi: 10.1007/s10637-026-01610-6. Epub 2026 Mar 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minsoo Park, PhD principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radotinib HCl in people with Drug Kinetics, run by Il-Yang Pharm. Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax(Maximum concentration of drug in plasma) (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06461078, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.