Clinical trial NCT05353010: A Study to Evaluate Effect of IN-A001 on Pharmacokinetics of Tacrolimus in Healthy Volunteers
Official title: Open-Label, 1-Sequence, 2-Period, Multiple Oral Dose Phase 1 Study to Evaluate Effect of IN-A001 on Pharmacokinetics of Tacrolimus in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2022-04-29
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Cmax of Tacrolimus
timeFrame: up to 72 hours(period 1), up to 240 hours(period 2)
measure: Tmax of Tacrolimus
timeFrame: up to 72 hours(period 1), up to 240 hours(period 2)
measure: AUClast of Tacrolimus
timeFrame: up to 72 hours(period 1), up to 240 hours(period 2)
measure: AUCinf of Tacrolimus
timeFrame: up to 72 hours(period 1), up to 240 hours(period 2)
measure: T1/2β of Tacrolimus
timeFrame: up to 72 hours(period 1), up to 240 hours(period 2)
Secondary outcomes:
measure: Point estimates and 90% CI for log (GMR of Period 2 Cmax, AUClast, AUCinf) / log (GMR of Period 1 Cmax, AUClast, AUCinf) of Tacrolimus
timeFrame: up to 72 hours(period 1), up to 240 hours(period 2)
measure: Cmax of Tegoprazan
timeFrame: up to 240 hours(period 2)
measure: Tmax of Tegoprazan
timeFrame: up to 240 hours(period 2)
measure: AUClast of Tegoprazan
timeFrame: up to 240 hours(period 2)
measure: AUCinf of Tegoprazan
timeFrame: up to 240 hours(period 2)
measure: T1/2β of Tegoprazan
timeFrame: up to 240 hours(period 2)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyun-Seop Bae, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: