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

NCT05353010 | Unknown Phase 1

• 1 other identifier: IN_APA_120
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Point estimates and 90% CI for log (GMR of Period 2 Cmax, AUClast, AUCinf) / log (GMR of Period 1 Cmax, AUClast, AUCinf) of Tacrolimus

  up to 72 hours(period 1), up to 240 hours(period 2)

• Cmax of Tegoprazan

  up to 240 hours(period 2)

• Tmax of Tegoprazan

  up to 240 hours(period 2)

• AUClast of Tegoprazan

  up to 240 hours(period 2)

• AUCinf of Tegoprazan

  up to 240 hours(period 2)

Study Arms (1)

Period 1: A; Period 2: B and C

EXPERIMENTAL

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

Interventions

Tacrolimus DRUG

Tacrolimus 5mg (1 mg \* 5 capsules)

Also known as: prograf

Period 1: A; Period 2: B and C

IN-A001(Tegoprazan) DRUG

IN-A001 50mg(Tegoprazan 50mg\* 1 tablet)

Also known as: K-CAB

Period 1: A; Period 2: B and C

IN-A001(Tegoprazan) + Tacrolimus DRUG

IN-A001 50mg(Tegoprazan 50mg\*1 tablet) and Tacrolimus 5mg(1mg \* 5capsules)

Also known as: IN-A001: K-CAB, Tacrolimus: Prograf

Period 1: A; Period 2: B and C

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Kyun-Seop Bae, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sohyun Kim

CONTACT

82-2-6477-0225; sohyun.kim21@inno-n.com

Nagyung Kim

CONTACT

82-2-6477-0195; nagyung.kim@inno-n.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 29, 2022
• Study Start: May 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: November 1, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-03

Locations

KR (1)