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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05353010
• Other study ID #: IN_APA_120
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 1, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: March 2022
• Source: HK inno.N Corporation
• Contact: Sohyun Kim
• Phone: 82-2-6477-0225
• Email: sohyun.kim21[@]inno-n.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: November 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Tacrolimus
Tacrolimus 5mg (1 mg * 5 capsules)
• IN-A001(Tegoprazan)
IN-A001 50mg(Tegoprazan 50mg* 1 tablet)
• IN-A001(Tegoprazan) + Tacrolimus
IN-A001 50mg(Tegoprazan 50mg*1 tablet) and Tacrolimus 5mg(1mg * 5capsules)

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of Tacrolimus	Maximum Plasma Concentration at Steady State of Tacrolimus	up to 72 hours(period 1), up to 240 hours(period 2)
Primary	Tmax of Tacrolimus	Time to Cmax at steady state	up to 72 hours(period 1), up to 240 hours(period 2)
Primary	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)
Primary	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)
Primary	T1/2ß of Tacrolimus	Half-life of the drug during elimination phase	up to 72 hours(period 1), up to 240 hours(period 2)
Secondary	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)
Secondary	Cmax of Tegoprazan	Maximum Plasma Concentration at Steady State of Tegoprazan	up to 240 hours(period 2)
Secondary	Tmax of Tegoprazan	Time to Cmax at steady state	up to 240 hours(period 2)
Secondary	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)
Secondary	AUCinf of Tegoprazan	Area under the curve from time 0 extrapolated to infinite time	up to 240 hours(period 2)
Secondary	T1/2ß of Tegoprazan	Half-life of the drug during elimination phase	up to 240 hours(period 2)