A Study to Evaluate Effect of IN-A001 on Pharmacokinetics of Tacrolimus in Healthy Volunteers
NCT ID: NCT05353010
Last Updated: 2022-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
12 participants
INTERVENTIONAL
2022-05-01
2022-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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
Tacrolimus
Tacrolimus 5mg (1 mg \* 5 capsules)
IN-A001(Tegoprazan)
IN-A001 50mg(Tegoprazan 50mg\* 1 tablet)
IN-A001(Tegoprazan) + Tacrolimus
IN-A001 50mg(Tegoprazan 50mg\*1 tablet) and Tacrolimus 5mg(1mg \* 5capsules)
Interventions
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Tacrolimus
Tacrolimus 5mg (1 mg \* 5 capsules)
IN-A001(Tegoprazan)
IN-A001 50mg(Tegoprazan 50mg\* 1 tablet)
IN-A001(Tegoprazan) + Tacrolimus
IN-A001 50mg(Tegoprazan 50mg\*1 tablet) and Tacrolimus 5mg(1mg \* 5capsules)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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).
3. 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
2. Has a history of malignancy
3. Has a history of gastrointestinal disease that may affect the absorption of investigational product.
4. Has genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption disorder etc.
5. History of hypersensitivity and severe allergic reaction to any of the components of IP.
6. Has participated in any other clinical study, etc. and received IPs within 180 days prior to the screening visit.
7. Excessive smoking (\> 10 cigarettes/day) within 14 days prior to the screening visit.
8. Excessive drinking ((\> 21 units/week) within 14 days prior to the screening visit.
9. 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;
10. 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
11. Determined ineligible for study participation by the investigator for other reasons.
19 Years
45 Years
ALL
Yes
Sponsors
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HK inno.N Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Kyun-Seop Bae, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Kyun-Seop Bae, MD, PhD
Role: primary
Other Identifiers
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IN_APA_120
Identifier Type: -
Identifier Source: org_study_id