Clinical trial NCT04633733: The Study of Pharmacokinetic Interactions Between HL237 and Tacrolimus
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Male Volunteers
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-18
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Fixed-sequential
Primary purpose: OTHER

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

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Peak plasma concentration at steady state(Cmax,ss) of HL237
timeFrame: 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
measure: Area under the plasma concentration versus time curve during a dosage interval(AUCτ) of HL237
timeFrame: 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
measure: Peak whole-blood concentration(Cmax) of tacrolimus
timeFrame: 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
measure: Area under the whole-blood concentration versus time curve from time zero to time of last measurable concentration(AUClast) of tacrolimus
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Korea Univertisy Anam Hospital
Study officials:
References: