Healthy Male VolunteersPhase 1NCT04633733
The Study of Pharmacokinetic Interactions Between HL237 and Tacrolimus
A Phase 1 study testing HL237 tablet and tacrolimus capsule in people with Healthy Male Volunteers, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
This study aims to evaluate the pharmacokinetic interaction between HL237 and tacrolimus in healthy male subjects. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- HL237 tablet and tacrolimus capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Aug 2020to Jan 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
This study aims to evaluate the pharmacokinetic interaction between HL237 and tacrolimus in healthy male subjects.
Read the 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).
- Conditions
- Healthy Male Volunteers
- Being tested
- HL237 tablet, tacrolimus capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL237 tabletDrug
HL237 400mg will be administered orally twice a day.
tacrolimus capsuleDrug
tacrolimus 5mg will be administered orally once a day.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: HL237 tablet; Drug: tacrolimus capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration at steady state(Cmax,ss) of HL237
Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start22 Aug 2020
- Primary completion24 Sep 2020
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Fixed-sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633733
- Sponsor's protocol ID
- HL237-103
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04633733
- Acronym / sponsor ID
- HL237-103
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2020 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- Jan 2021 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fixed-sequential
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: HL237 tablet, Drug: tacrolimus capsuleThis 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 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (25 listed)
- 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
- Subject with clinically significant active chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HL237 tabletHL237 400mg will be administered orally twice a day. | Drug | Single arm |
| tacrolimus capsuletacrolimus 5mg will be administered orally once a day. | Drug | Single arm |
Primary outcome
Peak plasma concentration at steady state(Cmax,ss) of HL237
Time frame: 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
Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237
Area under the plasma concentration versus time curve during a dosage interval(AUCτ) of HL237
Time frame: 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
Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237
Peak whole-blood concentration(Cmax) of tacrolimus
Time frame: 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
Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237
Area under the whole-blood concentration versus time curve from time zero to time of last measurable concentration(AUClast) of tacrolimus
Time frame: 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
Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HL237 tablet and tacrolimus capsule in people with Healthy Male Volunteers, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak plasma concentration at steady state(Cmax,ss) of HL237 (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.