A Study to Evaluate Effect of IN-A001 on Pharmacokinetics of Tacrolimus in Healthy Volunteers
Study Details
Study Description
Brief Summary
This study aims to investigate the effect of IN-A001 50mg on the pharmacokinetics of Tacrolimus 5mg in healthy volunteers
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Period 1: A; Period 2: B and C 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
Tacrolimus 5mg (1 mg * 5 capsules)
Other Names:
Drug: IN-A001(Tegoprazan)
IN-A001 50mg(Tegoprazan 50mg* 1 tablet)
Other Names:
Drug: IN-A001(Tegoprazan) + Tacrolimus
IN-A001 50mg(Tegoprazan 50mg*1 tablet) and Tacrolimus 5mg(1mg * 5capsules)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cmax of Tacrolimus [up to 72 hours(period 1), up to 240 hours(period 2)]
Maximum Plasma Concentration at Steady State of Tacrolimus
- Tmax of Tacrolimus [up to 72 hours(period 1), up to 240 hours(period 2)]
Time to Cmax at steady state
- AUClast of Tacrolimus [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 [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 [up to 72 hours(period 1), up to 240 hours(period 2)]
Half-life of the drug during elimination phase
Secondary Outcome Measures
- Point estimates and 90% CI for log (GMR of Period 2 Cmax, AUClast, AUCinf) / log (GMR of Period 1 Cmax, AUClast, AUCinf) of Tacrolimus [up to 72 hours(period 1), up to 240 hours(period 2)]
log(GMR of Period 2 Cmax, AUClast, AUCinf) / log (GMR of Period 1 Cmax, AUClast, AUCinf)
- Cmax of Tegoprazan [up to 240 hours(period 2)]
Maximum Plasma Concentration at Steady State of Tegoprazan
- Tmax of Tegoprazan [up to 240 hours(period 2)]
Time to Cmax at steady state
- AUClast of Tegoprazan [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 Tegoprazan [up to 240 hours(period 2)]
Area under the curve from time 0 extrapolated to infinite time
- T1/2β of Tegoprazan [up to 240 hours(period 2)]
Half-life of the drug during elimination phase
Eligibility Criteria
Criteria
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:
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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.
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Has participated in any other clinical study, etc. and received IPs within 180 days prior to the screening visit.
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Excessive smoking (> 10 cigarettes/day) within 14 days prior to the screening visit.
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Excessive drinking ((> 21 units/week) within 14 days prior to the screening visit.
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Has shown the following results from the laboratory test during the screening period.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Asan Medical Center | Seoul | Korea, Republic of |
Sponsors and Collaborators
- HK inno.N Corporation
Investigators
- Principal Investigator: Kyun-Seop Bae, MD, PhD, Asan Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IN_APA_120