HealthyPhase 1NCT05407220

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

A Phase 1 study testing HCP1904-1 and HCP1904-3 in people with Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers. 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
What is being tested?: HCP1904-1 and HCP1904-3
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteSouth Korea
Study dates: 29 Jun 2022to 25 Jul 2022
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

Age 19~45 years in healthy male volunteers
Weight ≥ 55kg and BMI 18 ~ 30 kg/m^2
Subjects who agree to use medically accepted dual contraceptives up to 14 days after the last administration date of the clinical trial drug and not to provide sperm.
Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Who cannot join

Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
Subjects who judged ineligible by the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Yangji Hospital
Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

Conditions: Healthy
Being tested: HCP1904-1, HCP1904-3

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HCP1904-1Drug
take it once per period
HCP1904-3Drug
take it once per period

Study groups in NCT05407220
Study group	Role	What they receive
group1	Experimental	Period1: HCP1904-1 Receives: Drug: HCP1904-1
group2	Experimental	Period1: HCP1904-3 Receives: Drug: HCP1904-3

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax of Losartan
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
AUC last of Losartan
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
AUC inf of Losartan
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Tmax of Losartan
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
t1/2 of Losartan
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
CL/F of Losartan
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Vd/F of Losartan
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Cmax of EXP3174
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
AUC last of EXP3174
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
AUC inf of EXP3174
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Tmax of EXP3174
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
t1/2 of EXP3174
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
CL/F of EXP3174
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Vd/F of EXP3174
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Cmax of Chlorthalidone
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
AUC last of Chlorthalidone
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
AUC inf of Chlorthalidone
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Tmax of Chlorthalidone
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
t1/2 of Chlorthalidone
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
CL/F of Chlorthalidone
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Vd/F of Chlorthalidone
pharmacokinetic evaluation
Measured: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jun 202225 Jul 2022

First posted7 Jun 2022
Study start29 Jun 2022
Primary completion25 Jul 2022
Study completion25 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05407220
Sponsor's protocol ID: HM-CHORUS-102
Status last verified: Oct 2024
First submitted: 27 May 2022
Last updated: 8 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.
ClinicalTrials.gov ID: NCT05407220
Acronym / sponsor ID: HM-CHORUS-102
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
Study start: 29 Jun 2022 (actual)
Primary completion: 25 Jul 2022 (actual)
Study completion: 25 Jul 2022 (actual)
First posted: 7 Jun 2022 (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.

A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
group1	Experimental	Drug: HCP1904-1Period1: HCP1904-1
group2	Experimental	Drug: HCP1904-3Period1: HCP1904-3

Who may qualify

Ages: 19 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Age 19~45 years in healthy male volunteers
Weight ≥ 55kg and BMI 18 ~ 30 kg/m^2
Subjects who agree to use medically accepted dual contraceptives up to 14 days after the last administration date of the clinical trial drug and not to provide sperm.
Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Key exclusion criteria (2 listed)

Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
Subjects who judged ineligible by the investigator

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
HCP1904-1take it once per period	Drug	group1
HCP1904-3take it once per period	Drug	group2

Primary outcome

Cmax of Losartan
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
AUC last of Losartan
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
AUC inf of Losartan
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Tmax of Losartan
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
t1/2 of Losartan
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
CL/F of Losartan
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Vd/F of Losartan
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Cmax of EXP3174
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
AUC last of EXP3174
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
AUC inf of EXP3174
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Tmax of EXP3174
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
t1/2 of EXP3174
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
CL/F of EXP3174
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Vd/F of EXP3174
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Cmax of Chlorthalidone
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
AUC last of Chlorthalidone
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
AUC inf of Chlorthalidone
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Tmax of Chlorthalidone
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
t1/2 of Chlorthalidone
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
CL/F of Chlorthalidone
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation
Vd/F of Chlorthalidone
Time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
pharmacokinetic evaluation

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
Individual participant dataSharing planned: No

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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 HCP1904-1 and HCP1904-3 in people with Healthy, run by Hanmi Pharmaceutical Company Limited 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 2 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: finished, as of the sponsor's last update on 8 Oct 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Cmax of Losartan (time frame: Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05407220.

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 8 Oct 2024.