The Study of Pharmacokinetic Interactions Between HL237 and Tacrolimus

NCT04633733 | Unknown Phase 1

• 1 other identifier: HL237-103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (4)

• 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

• Area under the plasma concentration versus time curve during a dosage interval(AUCτ) 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

• 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

• 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

Study Arms (1)

Single arm

EXPERIMENTAL

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

Drug: HL237 tablet; Drug: tacrolimus capsule

Interventions

HL237 tablet DRUG

HL237 400mg will be administered orally twice a day.

Single arm

tacrolimus capsule DRUG

tacrolimus 5mg will be administered orally once a day.

Single arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

The Korea Univertisy Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Design

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

Model Details: Fixed-sequential

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 18, 2020
• Study Start: August 22, 2020
• Primary Completion: September 24, 2020
• Study Completion: January 1, 2021
• Last Updated: November 18, 2020

Record last verified: 2020-11

Locations

KR (1)