The Study of Pharmacokinetic Interactions Between HL237 and Tacrolimus

Healthy Male Volunteers Clinical Trial

Official title:

An Open-label, Multiple-dose, Fixed-sequence, 3-Period Study to Evaluate the Pharmacokinetic Interactions Between HL237 and Tacrolimus in Healthy Male Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04633733
• Other study ID #: HL237-103
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: August 22, 2020
• Est. completion date: January 2021

Study information

• Verified date: November 2020
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the pharmacokinetic interaction between HL237 and tacrolimus in healthy male subjects.

Description:

To evaluate the pharmacokinetic interaction by comparing of pharmacokinetic parameters when administered HL237(or tacrolimus) between with tacrolimus(or HL237) and without tacrolimus(or HL237).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: January 2021
• Est. primary completion date: September 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy male, 19 years = age = 45

• Body weight = 50kg and 18.5 = BMI = 29.9kg/m2

• Subjects are agree to use contraceptives that protocol suggest and not provide sperm for up to 2 months after the last administration of the investigational drug

• Volunteer

Exclusion Criteria:

• Subject with serious cardiovascular, respiratory, hepatology, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease

• Subject with symptoms of acute disease within 28 days prior to investigational products dosing

• Subject with medical history which able to affect absorption, distribution, metabolism and excretion of drug

• Subject with hypersensitive reaction to following drug or history of clinically significant hypersensitive reaction to following drug

• Calcineurin inhibitor or Macrolides

• HL237

• Subject with clinically significant active chronic disease

• Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucosegalactose malabsorption

• Subjects who showed one or more of the following in a screening test including a retest

• AST, ALT > UNL (upper normal limit) x 2.5

• Creatinine clearance =< 80mL/min (Cockcroft-Gault GFR = (140-age) * (Wt in kg) / (72 * Cr))

• Results of ECG, QTc > 450 msec

• Positive test results for hepatitis B virus surface antigen, anti-hepatitis C virus antibody, anti-Human Immunodeficiency virus antibody or venereal disease research laboratory test

• Use of any prescription medication within 14 days prior to study medication dosing

• Use of any over-the-counter(OTC) medication within 7 days prior to study medication dosing

• Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)

• Subject who is not able to taking standard meals provided by the institution

• Subject with whole blood donation within 60 days, component blood donation within 20 days

• Subjects receiving blood transfusion within 30 days prior to study medication dosing

• Participation in any clinical investigation within 6 months prior to study medication dosing

• Use of any medication effected on drug enzyme induction or inhibition such as barbitals within 30 days prior to study medication dosing

• Subjects who have continuously consumed grapefruit juice or caffeine (grapefruit juice or caffeine > 5 cups/day), or who can't refrain from intake during hospitalization

• Subjects who have continued to drink alcohol (alcohol> 30 g/day) or who can't quit drinking during hospitalization

• Severe heavy smoker(cigarette > 10 cigarettes per day) or subjects who can't quit smoking during hospitalization

• Subjects that the investigator deems unsuitable for participation in the clinical trial due to laboratory test results or other excuse such as non-responding to request or instruction by investigator

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

Drug:
• HL237 tablet
HL237 400mg will be administered orally twice a day.
• tacrolimus capsule
tacrolimus 5mg will be administered orally once a day.

Locations

Country	Name	City	State
Korea, Republic of	The Korea Univertisy Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak plasma concentration at steady state(Cmax,ss) of HL237	Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237	0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour(after dosing) on day 21 and day 22
Primary	Area under the plasma concentration versus time curve during a dosage interval(AUCt) of HL237	Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237	0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour(after dosing) on day 21 and day 22
Primary	Peak whole-blood concentration(Cmax) of tacrolimus	Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237	0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hour(after dosing) on day 1 and day 22
Primary	Area under the whole-blood concentration versus time curve from time zero to time of last measurable concentration(AUClast) of tacrolimus	Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237	0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hour(after dosing) on day 1 and day 22