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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Tacrolimus; Drug: IN-A001(Tegoprazan); Drug: IN-A001(Tegoprazan) + Tacrolimus

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.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sohyun Kim; Phone Number: 82-2-6477-0225; Email: sohyun.kim21@inno-n.com
• Study Contact Backup: Name: Nagyung Kim; Phone Number: 82-2-6477-0195; Email: nagyung.kim@inno-n.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center
    • Contact: Kyun-Seop Bae, MD, PhD; Email: ksbae@amc.seoul.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Drug: Tacrolimus; Tacrolimus 5mg (1 mg * 5 capsules); Other Names: prograf; Drug: IN-A001(Tegoprazan); IN-A001 50mg(Tegoprazan 50mg* 1 tablet); Other Names: K-CAB; Drug: IN-A001(Tegoprazan) + Tacrolimus; IN-A001 50mg(Tegoprazan 50mg*1 tablet) and Tacrolimus 5mg(1mg * 5capsules); Other Names: IN-A001: K-CAB, Tacrolimus: Prograf

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of Tacrolimus	Maximum Plasma Concentration at Steady State of Tacrolimus	up to 72 hours(period 1), up to 240 hours(period 2)
Tmax of Tacrolimus	Time to Cmax at steady state	up to 72 hours(period 1), up to 240 hours(period 2)
AUClast of Tacrolimus	Area under the concentration-time curve from dosing (time 0) to the time of the last measured concentration	up to 72 hours(period 1), up to 240 hours(period 2)
AUCinf of Tacrolimus	Area under the curve from time 0 extrapolated to infinite time	up to 72 hours(period 1), up to 240 hours(period 2)
T1/2β of Tacrolimus	Half-life of the drug during elimination phase	up to 72 hours(period 1), up to 240 hours(period 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Point estimates and 90% CI for log (GMR of Period 2 Cmax, AUClast, AUCinf) / log (GMR of Period 1 Cmax, AUClast, AUCinf) of Tacrolimus	log(GMR of Period 2 Cmax, AUClast, AUCinf) / log (GMR of Period 1 Cmax, AUClast, AUCinf)	up to 72 hours(period 1), up to 240 hours(period 2)
Cmax of Tegoprazan	Maximum Plasma Concentration at Steady State of Tegoprazan	up to 240 hours(period 2)
Tmax of Tegoprazan	Time to Cmax at steady state	up to 240 hours(period 2)
AUClast of Tegoprazan	Area under the concentration-time curve from dosing (time 0) to the time of the last measured concentration	up to 240 hours(period 2)
AUCinf of Tegoprazan	Area under the curve from time 0 extrapolated to infinite time	up to 240 hours(period 2)
T1/2β of Tegoprazan	Half-life of the drug during elimination phase	up to 240 hours(period 2)

Collaborators and Investigators

• Sponsor: HK inno.N Corporation

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2022
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): November 1, 2022

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (ACTUAL): April 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: IN_APA_120

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No