HealthyPhase 1NCT05353010
A Study to Evaluate Effect of IN-A001 on Pharmacokinetics of Tacrolimus in Healthy Volunteers
A Phase 1 study testing Tacrolimus, IN-A001(Tegoprazan) and IN-A001(Tegoprazan) + Tacrolimus in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study aims to investigate the effect of IN-A001 50mg on the pharmacokinetics of Tacrolimus 5mg in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tacrolimus, IN-A001(Tegoprazan) and IN-A001(Tegoprazan) + Tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2022to 1 Nov 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index(BMI) ≥ 19.0 and ≤ 28.0 kg/m^2 at the time of screening.
- Those who agreed to use combination of effective or medically approved contraceptive method from the date of first administration of investigational product(IP) to the end of the clinical trial (when testing for final safety evaluation).
- In the case of female participant, who has negative result at the hCG urine pregnancy test and is not pregnant or currently breastfeeding.
Who cannot join
- Has clinically significant infections
- Has a history of malignancy
- Has a history of gastrointestinal disease that may affect the absorption of investigational product.
- Has genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption disorder etc.
- History of hypersensitivity and severe allergic reaction to any of the components of IP.
- Has participated in any other clinical study, etc. and received IPs within 180 days prior to the screening visit.
Show all 15Show fewer
- Excessive smoking (> 10 cigarettes/day) within 14 days prior to the screening visit.
- Excessive drinking ((> 21 units/week) within 14 days prior to the screening visit.
- Has shown the following results from the laboratory test during the screening period.
- AST, ALT level > 1.5 × ULN at screening;
- eGFR(estimated glomerular filtration rate) estimated on the basis of CKD-EPI is less than 60 mL/min/1.73 m2;
- Has shown the following results during the 12-lead electrocardiogram during the screening period.
- QTc > 450 ms
- Clinically significant abnormal rhythm and findings when the investigator medically determines
- Determined ineligible for study participation by the investigator for other reasons.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center
Seoul
Kyun-Seop Bae, MD, PhD, ksbae@amc.seoul.kr
About this study
Official title: Open-Label, 1-Sequence, 2-Period, Multiple Oral Dose Phase 1 Study to Evaluate Effect of IN-A001 on Pharmacokinetics of Tacrolimus in Healthy Volunteers
This study aims to investigate the effect of IN-A001 50mg on the pharmacokinetics of Tacrolimus 5mg in healthy volunteers
Read the detailed description
This is a open-label, 1-sequence, 2-period, multiple oral dose, phase 1 study. Healthy subjects will be assigned to a group and sequentially administerd Tacrolimus and IN-A001.
- Conditions
- Healthy
- Being tested
- Tacrolimus, IN-A001(Tegoprazan), IN-A001(Tegoprazan) + Tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called prograf
Tacrolimus 5mg (1 mg * 5 capsules)
IN-A001(Tegoprazan)Drug
Also called K-CAB
IN-A001 50mg(Tegoprazan 50mg* 1 tablet)
IN-A001(Tegoprazan) + TacrolimusDrug
Also called IN-A001: K-CAB, Tacrolimus: Prograf
IN-A001 50mg(Tegoprazan 50mg*1 tablet) and Tacrolimus 5mg(1mg * 5capsules)
| Study group | Role | What they receive |
|---|---|---|
| Period 1: A; Period 2: B and C | Experimental | A: Oral Administration of Tacrolimus 5mg once / B: Oral Administration of IN-A001(Tegoprazan) 50mg QD for 7 days / C: Oral Administration of IN-A001(Tegoprazan) 50mg + Tacrolimus 5mg once Receives: Drug: Tacrolimus; Drug: IN-A001(Tegoprazan); Drug: IN-A001(Tegoprazan) + Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Tacrolimus
Maximum Plasma Concentration at Steady State of Tacrolimus
Measured: up to 72 hours(period 1), up to 240 hours(period 2)
Tmax of Tacrolimus
Time to Cmax at steady state
Measured: up to 72 hours(period 1), up to 240 hours(period 2)
AUClast of Tacrolimus
Area under the concentration-time curve from dosing (time 0) to the time of the last measured concentration
Measured: up to 72 hours(period 1), up to 240 hours(period 2)
AUCinf of Tacrolimus
Area under the curve from time 0 extrapolated to infinite time
Measured: up to 72 hours(period 1), up to 240 hours(period 2)
T1/2β of Tacrolimus
Half-life of the drug during elimination phase
Measured: up to 72 hours(period 1), up to 240 hours(period 2)
Secondary outcomes (6)
Point estimates and 90% CI for log (GMR of Period 2 Cmax, AUClast, AUCinf) / log (GMR of Period 1 Cmax, AUClast, AUCinf) of Tacrolimus
log(GMR of Period 2 Cmax, AUClast, AUCinf) / log (GMR of Period 1 Cmax, AUClast, AUCinf)
Measured: up to 72 hours(period 1), up to 240 hours(period 2)
Cmax of Tegoprazan
Maximum Plasma Concentration at Steady State of Tegoprazan
Measured: up to 240 hours(period 2)
Tmax of Tegoprazan
Time to Cmax at steady state
Measured: up to 240 hours(period 2)
AUClast of Tegoprazan
Area under the concentration-time curve from dosing (time 0) to the time of the last measured concentration
Measured: up to 240 hours(period 2)
AUCinf of Tegoprazan
Area under the curve from time 0 extrapolated to infinite time
Measured: up to 240 hours(period 2)
T1/2β of Tegoprazan
Half-life of the drug during elimination phase
Measured: up to 240 hours(period 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyun-Seop Bae, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353010
- Sponsor's protocol ID
- IN_APA_120
- Status last verified
- Mar 2022
- First submitted
- 25 Apr 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, 1-Sequence, 2-Period, Multiple Oral Dose Phase 1 Study to Evaluate Effect of IN-A001 on Pharmacokinetics of Tacrolimus in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05353010
- Acronym / sponsor ID
- IN_APA_120
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 29 Apr 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 aims to investigate the effect of IN-A001 50mg on the pharmacokinetics of Tacrolimus 5mg in healthy volunteers
Detailed description
This is a open-label, 1-sequence, 2-period, multiple oral dose, phase 1 study. Healthy subjects will be assigned to a group and sequentially administerd Tacrolimus and IN-A001.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Period 1: A; Period 2: B and C | Experimental | Drug: Tacrolimus, Drug: IN-A001(Tegoprazan), Drug: IN-A001(Tegoprazan) + TacrolimusA: Oral Administration of Tacrolimus 5mg once / B: Oral Administration of IN-A001(Tegoprazan) 50mg QD for 7 days / C: Oral Administration of IN-A001(Tegoprazan) 50mg + Tacrolimus 5mg once |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index(BMI) ≥ 19.0 and ≤ 28.0 kg/m^2 at the time of screening.
- Those who agreed to use combination of effective or medically approved contraceptive method from the date of first administration of investigational product(IP) to the end of the clinical trial (when testing for final safety evaluation).
- In the case of female participant, who has negative result at the hCG urine pregnancy test and is not pregnant or currently breastfeeding.
Key exclusion criteria (15 listed)
- Has clinically significant infections
- Has a history of malignancy
- Has a history of gastrointestinal disease that may affect the absorption of investigational product.
- Has genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption disorder etc.
- History of hypersensitivity and severe allergic reaction to any of the components of IP.
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 |
|---|---|---|
| TacrolimusAlso: prografTacrolimus 5mg (1 mg * 5 capsules) | Drug | Period 1: A; Period 2: B and C |
| IN-A001(Tegoprazan)Also: K-CABIN-A001 50mg(Tegoprazan 50mg* 1 tablet) | Drug | Period 1: A; Period 2: B and C |
| IN-A001(Tegoprazan) + TacrolimusAlso: IN-A001: K-CAB, Tacrolimus: PrografIN-A001 50mg(Tegoprazan 50mg*1 tablet) and Tacrolimus 5mg(1mg * 5capsules) | Drug | Period 1: A; Period 2: B and C |
Primary outcome
Cmax of Tacrolimus
Time frame: up to 72 hours(period 1), up to 240 hours(period 2)
Maximum Plasma Concentration at Steady State of Tacrolimus
Tmax of Tacrolimus
Time frame: up to 72 hours(period 1), up to 240 hours(period 2)
Time to Cmax at steady state
AUClast of Tacrolimus
Time frame: up to 72 hours(period 1), up to 240 hours(period 2)
Area under the concentration-time curve from dosing (time 0) to the time of the last measured concentration
AUCinf of Tacrolimus
Time frame: up to 72 hours(period 1), up to 240 hours(period 2)
Area under the curve from time 0 extrapolated to infinite time
T1/2β of Tacrolimus
Time frame: up to 72 hours(period 1), up to 240 hours(period 2)
Half-life of the drug during elimination phase
6 secondary outcomes
Point estimates and 90% CI for log (GMR of Period 2 Cmax, AUClast, AUCinf) / log (GMR of Period 1 Cmax, AUClast, AUCinf) of Tacrolimus
Time frame: up to 72 hours(period 1), up to 240 hours(period 2)
Cmax of Tegoprazan
Time frame: up to 240 hours(period 2)
Tmax of Tegoprazan
Time frame: up to 240 hours(period 2)
AUClast of Tegoprazan
Time frame: up to 240 hours(period 2)
AUCinf of Tegoprazan
Time frame: up to 240 hours(period 2)
T1/2β of Tegoprazan
Time frame: up to 240 hours(period 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
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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.
Kyun-Seop Bae, MD, PhD principal investigator
Asan Medical Center
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 Tacrolimus, IN-A001(Tegoprazan) and IN-A001(Tegoprazan) + Tacrolimus in people with Healthy, run by HK inno.N Corporation 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 3 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 29 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sohyun Kim (82-2-6477-0225, sohyun.kim21@inno-n.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of Tacrolimus (time frame: up to 72 hours(period 1), up to 240 hours(period 2)). The study lists 5 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 29 Apr 2022.