A Study to Evaluate Effect of IN-A001 on Pharmacokinetics of Tacrolimus in Healthy Volunteers

Study Overview
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Brief Summary
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This study aims to investigate the effect of IN-A001 50mg on the pharmacokinetics of Tacrolimus 5mg in healthy volunteers

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Tacrolimus
* Drug: IN-A001(Tegoprazan)
* Drug: IN-A001(Tegoprazan) + Tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Period 1: A; Period 2: B and C<br>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 | Drug: Tacrolimus<br>* Tacrolimus 5mg (1 mg * 5 capsules)<br>* Other names: prograf;Drug: IN-A001(Tegoprazan)<br>* IN-A001 50mg(Tegoprazan 50mg* 1 tablet)<br>* Other names: K-CAB;Drug: IN-A001(Tegoprazan) + Tacrolimus<br>* IN-A001 50mg(Tegoprazan 50mg*1 tablet) and Tacrolimus 5mg(1mg * 5capsules)<br>* Other names: IN-A001: K-CAB, Tacrolimus: Prograf;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Tacrolimus | Maximum Plasma Concentration at Steady State of Tacrolimus | up to 72 hours(period 1), up to 240 hours(period 2) | 
| Tmax of Tacrolimus | Time to Cmax at steady state | 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 | 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 | up to 72 hours(period 1), up to 240 hours(period 2) | 
| T1/2β of Tacrolimus | Half-life of the drug during elimination phase | up to 72 hours(period 1), up to 240 hours(period 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | up to 72 hours(period 1), up to 240 hours(period 2) | 
| Cmax of Tegoprazan | Maximum Plasma Concentration at Steady State of Tegoprazan | up to 240 hours(period 2) | 
| Tmax of Tegoprazan | Time to Cmax at steady state | 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 | up to 240 hours(period 2) | 
| AUCinf of Tegoprazan | Area under the curve from time 0 extrapolated to infinite time | up to 240 hours(period 2) | 
| T1/2β of Tegoprazan | Half-life of the drug during elimination phase | up to 240 hours(period 2) |