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

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: HK inno.N Corporation
• Treatments: Tacrolimus

Criteria

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.