Healthy VolunteerPhase 1NCT04225052
Clinical Trial to Evaluate the Safety and Pharmacokinetics of YHP1903 in Healthy Volunteers
A Phase 1 study testing YHP1903 and Champix in people with Healthy Volunteer, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
A randomized, open-label, single dose, crossover clinical trial to evaluate the safety and pharmacokinetics of YHP1903 in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- YHP1903 and Champix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Dec 2019to 14 Jan 2020
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male/female aged 19 to 55 with body mass index(BMI) between 18.5 and 30kg/m2
- Acceptable medical history, physical examination, laboratory tests and EKG, during screening
- Subjects who has signed a written informed consent voluntarily,prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
Who cannot join
- History of clinically significant disease
- Sitting blood pressure meeting the following criteria at screening:
- 140 ≤ systolic blood pressure ≤90 (mmHg)
- 90 ≤ diastolic blood pressure ≤ 60 (mmHg)
- Have AST(SGOT) or/and ALT(SGPT) > 1.5 times of normal upper limit or Total bilirubin > 2.0 mg/dl at the time of screening
- Volunteers considered not eligible for the clinical trial by the investigator
- Administration of other investigational products within 6 month prior to the first dosing.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonbuk national university hospital
Jeonju, Jeollabuk-do, 54907
About this study
Official title: A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1903 in Healthy Volunteers
A randomized, open-label, single dose, crossover clinical trial to evaluate the safety and pharmacokinetics of YHP1903 in healthy volunteers
Read the detailed description
32 healthy subjects wil be randomized one of 2 groups in the same ratio. Subjects in group 1 will be administered "comparator" and "YHP1903" by cross-over design on day1, 8.
Subjects in group 2 will be administered "YHP1903" and "comparator" by cross-over design on day1, 8.
- Conditions
- Healthy Volunteer
- Being tested
- YHP1903, Champix
- Keywords
- Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YHP1903Drug
YHP1903 Tab. 1mg
ChampixDrug
Comparator Champix Tab. 1mg
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Other | 16 subjects, Cross-over, Single dose of comparator on day1, Single dose of YHP1903 on day8 Receives: Drug: YHP1903; Drug: Champix |
| Group2 | Other | 16 subjects, Cross-over, Single dose of YHP1903 on day1, Single dose of comparator on day8 Receives: Drug: YHP1903; Drug: Champix |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
AUCt of Varenicline
Measured: 0-96 hours
Cmax
Cmax of Varenicline
Measured: 0-96 hours
Secondary outcomes (3)
AUCinf
AUCinf of Varenicline
Measured: 0-96 hours
Tmax
Tmax of Varenicline
Measured: 0-96 hours
t1/2
t1/2 of Varenicline
Measured: 0-96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start19 Dec 2019
- Primary completion8 Jan 2020
- Study completion14 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chonbuk National University Hospital
- Responsible party
- Sponsor
- Investigators
- Mingul Kim, PhD, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225052
- Sponsor's protocol ID
- YHP1903-101
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1903 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04225052
- Acronym / sponsor ID
- YHP1903-101
- Conditions
- Healthy Volunteer
- Keywords
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Chonbuk National University Hospital
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 13 Jan 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.
A randomized, open-label, single dose, crossover clinical trial to evaluate the safety and pharmacokinetics of YHP1903 in healthy volunteers
Detailed description
32 healthy subjects wil be randomized one of 2 groups in the same ratio. Subjects in group 1 will be administered "comparator" and "YHP1903" by cross-over design on day1, 8.
Subjects in group 2 will be administered "YHP1903" and "comparator" by cross-over design on day1, 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 | Other | Drug: YHP1903, Drug: Champix16 subjects, Cross-over, Single dose of comparator on day1, Single dose of YHP1903 on day8 |
| Group2 | Other | Drug: YHP1903, Drug: Champix16 subjects, Cross-over, Single dose of YHP1903 on day1, Single dose of comparator on day8 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male/female aged 19 to 55 with body mass index(BMI) between 18.5 and 30kg/m2
- Acceptable medical history, physical examination, laboratory tests and EKG, during screening
- Subjects who has signed a written informed consent voluntarily,prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
Key exclusion criteria (7 listed)
- History of clinically significant disease
- Sitting blood pressure meeting the following criteria at screening:
- Have AST(SGOT) or/and ALT(SGPT) > 1.5 times of normal upper limit or Total bilirubin > 2.0 mg/dl at the time of screening
- Volunteers considered not eligible for the clinical trial by the investigator
- Administration of other investigational products within 6 month prior to the first dosing.
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 |
|---|---|---|
| YHP1903YHP1903 Tab. 1mg | Drug | Group1, Group2 |
| ChampixComparator Champix Tab. 1mg | Drug | Group1, Group2 |
Primary outcome
AUCt
Time frame: 0-96 hours
AUCt of Varenicline
Cmax
Time frame: 0-96 hours
Cmax of Varenicline
3 secondary outcomes
AUCinf
Time frame: 0-96 hours
Tmax
Time frame: 0-96 hours
t1/2
Time frame: 0-96 hours
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 23 Jan 2020.
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Screening Protocol
Pain
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.
Mingul Kim, PhD principal investigator
Chonbuk National University Hospital
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 YHP1903 and Champix in people with Healthy Volunteer, run by Yuhan Corporation 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 3 inclusion and 7 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 23 Jan 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?
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?
AUCt (time frame: 0-96 hours). The study lists 2 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 23 Jan 2020.