The Study of Pharmacokinetic Interactions Between HL237 and Tacrolimus

Hanlim Pharm

Status and phase: Unknown; Phase 1

Conditions: Healthy Male Volunteers

Treatments: Drug: HL237 tablet; Drug: tacrolimus capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT04633733

HL237-103

Details and patient eligibility

About

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

Full 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).

Enrollment: 24 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

24 participants in 1 patient group

Single arm

Experimental group

Description:

This single arm is conducted in fixed-sequence(Treatment A -\>(washout period) -\> Treatment B -\> Treatment C -\> Maintenance treatment). Treatment A : tacrolimus 5mg po single dose, Treatment B : HL237 400mg bid for 4 days, Treatment C: tacrolimus 5mg po single dose and HL237 400 mg bid, Maintenance treatment : HL237 400mg bid for 2 days

Treatment:

Drug: HL237 tablet

Drug: tacrolimus capsule