PharmacokineticsPhase 1NCT05509543
Study to Evaluate the Safety and the Pharmacokinetics of IY-NT-T
A Phase 1 study testing IY-NT-T and IY-NT-R in people with Pharmacokinetics, run by Il-Yang Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
This study evaluate the pharmacokinetic and safety of IY-NT-T in healthy adults Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- IY-NT-T and IY-NT-R
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Aug 2022to 18 Dec 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers aged 19 years and above at screening
- A volunteer who weighs ≥ 50kg (≥ 45kg for women) and has a body mass index(BMI)* of ≥18.0 and ≤ 30 at screening
- BMI(body mass index, kg/m^2)= Body weight (kg)/[height (m)^2]
- A volunteer who has no congenital or chronic diseases, no pathological symptoms, or findings from medical examination at screening
- A volunteer who is determined by the principal investigator or sub-investigator(responsible physician) as eligible as a subject based on diagnostic tests( hematology, hematochemical, serum, urinalysis) and electrocardiogram tests established and conducted according to the characteristics of the study drug
- A volunteer and their spouse or partner, who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 7 days after the last dose of study drug
- Contraception methods: Intrauterine device, vasectomy, tubal ligation and contraceptive barrier methods (male condoms, women condoms, cervical caps. Contraceptive diaphragm, sponge,etc) used in combination or if spermicide is used, two or more contraceptive barrier methods
- A volunteer who voluntarily provided written consent to participation in the entire study process after being fully informed of the study objective, contents, characteristics of the study drugs, and expected adverse reactions, prior to study participation
Who cannot join
- A volunteer who has a history or present symptoms of clinically significant disorders relating to any of the following: digestive system, cardiovascular system, endocrine system, respiratory system, blood and lymphatic, infectious disease, renal, urinary, and reproductive, system, nervous system, musculoskeletal system, immune system, otolaryngology, skin and subcutaneous tissue system, and ophthalmic system
- A volunteer who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases
- A volunteer who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month prior to the first dose or who has taken drugs that may interfere with clinical study within 10 days prior to the first dose(Provided that, participation may be considered based on drug-drug interaction, pharmacokinetics and pharmacodynamics(such as half-life) of study drug)
- A volunteer who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the study drug
- A volunteer who has participated in whole blood donation within 8 weeks prior to first dose, or apheresis donation within w weeks prior to first dose, or received blood donation within 4 weeks prior to first dose.
- A volunteer that meets any of the following conditions within 1 month prior to first dose
Show all 18Show fewer
- Average alcohol intake(for men): > 21 glass/week
- Average alcohol intake(for women): > 14 glass/week (1 glass = 50ml of soju or 30ml of liquor, or 250ml of beer)
- Average cigarette smoking: > 20 cigarettes per day.
- A volunteer that meets any of the following categories
- Volunteer who is hypersensitive to the active ingredient or other ingredients of this drug
- Patients that meet any of the following conditions
- Gastric ulcer patients possibly related to a malignant tumor
- Hepatic disorder or renal disorder patients
- Patients receiving Atazanavir
- Patients receiving Rilpivirine-containing products
- A volunteer who is considered by the investigator to be ineligible to participate in this study for other reasons
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of IY-NT-T in Healthy Adult Volunteers Under Fasting Conditions
This study evaluate the pharmacokinetic and safety of IY-NT-T in healthy adults
Read the detailed description
Phase 1 study to evaluate the safety and the pharmacokinetics of IY-NT-T in healthy adult volunteers under fasting conditions
- Conditions
- Pharmacokinetics
- Being tested
- IY-NT-T, IY-NT-R
- Keywords
- proton pump inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IY-NT-TDrug
Ilaprazole 20mg
IY-NT-RDrug
Also called Noltec(the brand name)
Ilaprazole 10mg
| Study group | Role | What they receive |
|---|---|---|
| A group | Active comparator | Period 1 : Ilaprazole 10mg 2Tab, one a day
Period 2 : Ilaprazole 20mg 1Tab, one a day Receives: Drug: IY-NT-T; Drug: IY-NT-R |
| B group | Active comparator | Period 1 : Ilaprazole 20mg 1Tab, one a day
Period 2 : Ilaprazole 10mg 2Tab, one a day Receives: Drug: IY-NT-T; Drug: IY-NT-R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ilaprazole AUCt
ilaprazole AUCt(Area under the concentration-time curve)
Measured: Predose(0hour), after dose 0.5hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 4.5hours, 5hours, 6hours, 8hours, 10hours, 12hours, 24hours
Ilaprazole Cmax
ilaprazole Cmax(Maximum concentration of drug in plasma)
Measured: Predose(0hour), after dose 0.5hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 4.5hours, 5hours, 6hours, 8hours, 10hours, 12hours, 24hours
Secondary outcomes (3)
Ilaprazole AUC∞
ilaprazole AUC∞(Area under the plasma drug concentration-time curve from time 0 to infinity)
Measured: Predose(0hour), after dose 0.5hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 4.5hours, 5hours, 6hours, 8hours, 10hours, 12hours, 24hours
Ilaprazole tmax
ilaprazole tmax(Time to maximum plasma concentration)
Measured: Predose(0hour), after dose 0.5hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 4.5hours, 5hours, 6hours, 8hours, 10hours, 12hours, 24hours
Ilaprazole t1/2
ilaprazole t1/2(Terminal elimination half-life)
Measured: Predose(0hour), after dose 0.5hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 4.5hours, 5hours, 6hours, 8hours, 10hours, 12hours, 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start24 Aug 2022
- Primary completion22 Oct 2022
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae Woo Kim, MD, PhD, Principal investigator, H Plus Yangji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509543
- Sponsor's protocol ID
- DTC22-IP017
- Status last verified
- Jun 2024
- First submitted
- 18 Aug 2022
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of IY-NT-T in Healthy Adult Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT05509543
- Acronym / sponsor ID
- DTC22-IP017
- Conditions
- Pharmacokinetics
- Keywords
- proton pump inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 22 Oct 2022 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 22 Aug 2022 (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.
This study evaluate the pharmacokinetic and safety of IY-NT-T in healthy adults
Detailed description
Phase 1 study to evaluate the safety and the pharmacokinetics of IY-NT-T in healthy adult volunteers under fasting conditions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | Active comparator | Drug: IY-NT-T, Drug: IY-NT-RPeriod 1 : Ilaprazole 10mg 2Tab, one a day Period 2 : Ilaprazole 20mg 1Tab, one a day |
| B group | Active comparator | Drug: IY-NT-T, Drug: IY-NT-RPeriod 1 : Ilaprazole 20mg 1Tab, one a day Period 2 : Ilaprazole 10mg 2Tab, one a day |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Volunteers aged 19 years and above at screening
- A volunteer who weighs ≥ 50kg (≥ 45kg for women) and has a body mass index(BMI)* of ≥18.0 and ≤ 30 at screening
- BMI(body mass index, kg/m^2)= Body weight (kg)/[height (m)^2]
- A volunteer who has no congenital or chronic diseases, no pathological symptoms, or findings from medical examination at screening
- A volunteer who is determined by the principal investigator or sub-investigator(responsible physician) as eligible as a subject based on diagnostic tests( hematology, hematochemical, serum, urinalysis) and electrocardiogram tests established and conducted according to the characteristics of the study drug
Key exclusion criteria (18 listed)
- A volunteer who has a history or present symptoms of clinically significant disorders relating to any of the following: digestive system, cardiovascular system, endocrine system, respiratory system, blood and lymphatic, infectious disease, renal, urinary, and reproductive, system, nervous system, musculoskeletal system, immune system, otolaryngology, skin and subcutaneous tissue system, and ophthalmic system
- A volunteer who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases
- A volunteer who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month prior to the first dose or who has taken drugs that may interfere with clinical study within 10 days prior to the first dose(Provided that, participation may be considered based on drug-drug interaction, pharmacokinetics and pharmacodynamics(such as half-life) of study drug)
- A volunteer who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the study drug
- A volunteer who has participated in whole blood donation within 8 weeks prior to first dose, or apheresis donation within w weeks prior to first dose, or received blood donation within 4 weeks prior to first dose.
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 |
|---|---|---|
| IY-NT-TIlaprazole 20mg | Drug | A group, B group |
| IY-NT-RAlso: Noltec(the brand name)Ilaprazole 10mg | Drug | A group, B group |
Primary outcome
Ilaprazole AUCt
Time frame: Predose(0hour), after dose 0.5hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 4.5hours, 5hours, 6hours, 8hours, 10hours, 12hours, 24hours
ilaprazole AUCt(Area under the concentration-time curve)
Ilaprazole Cmax
Time frame: Predose(0hour), after dose 0.5hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 4.5hours, 5hours, 6hours, 8hours, 10hours, 12hours, 24hours
ilaprazole Cmax(Maximum concentration of drug in plasma)
3 secondary outcomes
Ilaprazole AUC∞
Time frame: Predose(0hour), after dose 0.5hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 4.5hours, 5hours, 6hours, 8hours, 10hours, 12hours, 24hours
Ilaprazole tmax
Time frame: Predose(0hour), after dose 0.5hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 4.5hours, 5hours, 6hours, 8hours, 10hours, 12hours, 24hours
Ilaprazole t1/2
Time frame: Predose(0hour), after dose 0.5hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 4.5hours, 5hours, 6hours, 8hours, 10hours, 12hours, 24hours
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 20 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Jae Woo Kim, MD, PhD principal investigator
H Plus Yangji 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 IY-NT-T and IY-NT-R in people with Pharmacokinetics, 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 8 inclusion and 18 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 20 Jun 2024. 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?
Ilaprazole AUCt (time frame: Predose(0hour), after dose 0.5hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 4.5hours, 5hours, 6hours, 8hours, 10hours, 12hours, 24hours). 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?
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 20 Jun 2024.