Status:
UNKNOWN
A Study to Evaluate Effect of IN-A001 on Pharmacokinetics of Tacrolimus in Healthy Volunteers
Lead Sponsor:
HK inno.N Corporation
Conditions:
Healthy
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
Brief Summary
This study aims to investigate the effect of IN-A001 50mg on the pharmacokinetics of Tacrolimus 5mg in healthy volunteers
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05353010
Start Date
May 1 2022
End Date
November 1 2022
Last Update
April 29 2022
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea