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

HK inno.N

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: IN-A001(Tegoprazan); Drug: IN-A001(Tegoprazan) + Tacrolimus; Drug: Tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT05353010

IN_APA_120

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Body mass index(BMI) ≥ 19.0 and ≤ 28.0 kg/m^2 at the time of screening.
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

1. Has clinically significant infections

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Period 1: A; Period 2: B and C

Experimental group

Description:

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

Treatment:

Drug: Tacrolimus

Drug: IN-A001(Tegoprazan)

Drug: IN-A001(Tegoprazan) + Tacrolimus